Skip to content | Skip to institutional links

Common menu bar links

Institutional links

Current Subject
- Drugs & Health Products
- Compliance & Enforcement
Explore...
Proactive Disclosure

Proactive Disclosure

Drugs and Health Products

Print |

Need Larger Text? |

(From April 2009 - June 2009)

Trade Name

Manufacturer

Recall Posting Date

Drug and Medical Device Recall Listings

Manufacturer: 3M Canada Company
Recall Posting Date: 2009-05-25
Trade Name: Nexcare Opticlude Orthoptic Eye Patch
Recall Start Date: 2009-05-05
Recall Number: 48185
Hazard Classification: Type III
Model or Catalog #: 1539
Lot or Serial #: 900605, 902007, 902106
Reason for Recall: The primary boxes from these affected lots may not have the application instructions and caution statements printed on the inside flaps of the primary box, as otherwise indicated.

Top of Page

Manufacturer: Abbott Laboratories Diagnostic Division
Recall Posting Date: 2009-04-27
Trade Name: A) Cell-Dyn 3700 SL Analyzer
B) Cell-Dyn 3700 CS Analyzer
Recall Start Date: 2009-04-01
Recall Number: 47694
Hazard Classification: Type III
Model or Catalog #: A) 02H31-01
B) 02H30-01
Lot or Serial #: A) All Serial Numbers
B) All Serial Numbers
Reason for Recall: There have been occurrences of visible fire and smoke from the analyzer. They may contain the incorrect fuse for the electrical configuration at the customer site.

Top of Page

Manufacturer: Abbott Laboratories Diagnostic Division
Recall Posting Date: 2009-06-22
Trade Name: Architect Reaction Vessel
Recall Start Date: 2009-05-19
Recall Number: 48605
Hazard Classification: Type II
Model or Catalog #: 7C15-01
Lot or Serial #: > 10 Numbers, Contact Manufactuer
Reason for Recall: Reaction vessels made from specific lots of resin had an increased likelihood of producing error code 1006 and error code 1007 and incorrect/elevated results.

Top of Page

Manufacturer: Abbott Point Of Care Inc.
Recall Posting Date: 2009-05-25
Trade Name: i-STAT 1 Analyzer System-Instrument
Recall Start Date: 2009-04-27
Recall Number: 48245
Hazard Classification: Type II
Model or Catalog #: 06F16-10
Lot or Serial #: >100 Numbers, Contact Manufacturer
Reason for Recall: The rechargeable battery pack can overheat with or without the presence of smoke causing the Martel printer to overheat in the i-STAT 1 analyzer system.

Top of Page

Manufacturer: Ace Surgical Supply Co. Inc.
Recall Posting Date: 2009-04-13
Trade Name: 5/0 Polyglycolic Acid Absorbable Suture
Recall Start Date: 2009-02-24
Recall Number: 47393
Hazard Classification: Type II
Model or Catalog #: 34630
Lot or Serial #: 081031-07
Reason for Recall: A small and limited number of packaged product demonstrated a partial delamination, or coming apart, of the two layers of material that make up the clear portion of the outer packaging.

Top of Page

Manufacturer: Acist Medical Systems Inc.
Recall Posting Date: 2009-06-08
Trade Name: Acist Angiographic System-Manifold Kit
Recall Start Date: 2009-05-13
Recall Number: 48480
Hazard Classification: Type II
Model or Catalog #: BT2000
Lot or Serial #: 3168H
Reason for Recall: The manufacturer has received field reports of a bulge and leaks on the side of the 2.5" high-pressure tubing of BT2000 kits during a procedure which can result in unsatisfactory performance of the product.

Top of Page

Manufacturer: Advanced Sterilization Products, A Division Of Ethicon
Recall Posting Date: 2009-04-27
Trade Name: A) Sterrad 50 Sterilizer System
B) Sterrad NX Sterilizer System
Recall Start Date: 2009-03-13
Recall Number: 47825
Hazard Classification: Type II
Model or Catalog #: A) 10050
B) 10033
Lot or Serial #: A) > 10 Numbers, Contact Manufacturer
B) > 10 Numbers, Contact Manufacturer
Reason for Recall: The Sterrad 50 system may potentially have defective oil fill plugs. Degradation of the nylon 6-6 plugs over time, if exposed to hydrogen peroxide, can contribute to emission of oil mist from the sterilizer.

Top of Page

Manufacturer: Alcon Grieshabe AG
Recall Posting Date: 2009-04-27
Trade Name: A) Grieshaber Handpiece, MPC Microscissors
B) Vertical Scissors
Recall Start Date: 2009-04-06
Recall Number: 47782
Hazard Classification: Type II
Model or Catalog #: A) 705.52
B) 704.52
Lot or Serial #: A) F53125, F58670, F65194, F67471, F69429
B) F61426, F63004
Reason for Recall: New metal cannula assemblies are scheduled for launch in June 2009. These new metal cannula may have a tolerance stack up issue with selected lots of these scissors.

Top of Page

Manufacturer: Alcon Laboratories Inc.
Recall Posting Date: 2009-06-08
Trade Name: Custom-Pak Opthalmic Surgery Pak
Recall Start Date: 2009-05-01
Recall Number: 48472
Hazard Classification: Type II
Model or Catalog #: 13305-01
Lot or Serial #: 894213H
Reason for Recall: Identification of oxidization on some of the 25GA Trocar Blades packaged in the 25GA Total Plus paks which are part of the Alcon custom-pak procedure pack.

Top of Page

Manufacturer: Ansell Healthcare Products LLC
Recall Posting Date: 2009-05-25
Trade Name: Derma Prene Ultra Surgical Glove
Recall Start Date: 2009-05-04
Recall Number: 48229
Hazard Classification: Type II
Model or Catalog #: 851365, 851470
Lot or Serial #: 0810006605, 0810006705
Reason for Recall: Some gloves may be discoloured as a result of film degradation. This degradation results in film strength properties below the ASTM performance standard for surgeon's gloves.

Top of Page

Manufacturer: Arrow International, Inc.
Recall Posting Date: 2009-04-13
Trade Name: A) Percutaneous Sheath Procedural Kits
B) Central Venous Catheterization Set/Kit
C) Temporary Pacing Catheter
D) Two-lumen Central Catheterization Kit
E) Percutaneous Sheath Introducer Sets
F) Stopcocks
G) Arterial Access Products
H) Thrombolic Device Rotator Drive Unit
I) Tretorola Percutaneous Thombolic Device
J) Percutaneous Sheath Introducer
K) Super Arrow-Flex Percut Sheath Intro
L) Stopcock with Luer Lock
M) Stopcock Manifold
N) Multi-Lumen Percut Sheath Introducer
O) Stopcock with Luer Lock
P) Stopcock with Luer Lock
Q) Blood Administration Sets
R) Extension Sets
S) Trerotola Percut. Thrombolytic Kit
Recall Start Date: 2009-02-18
Recall Number: 46908
Hazard Classification: Type II
Model or Catalog #: A) AK-09903-J, CA-09803, CA-09886, CA-09903-LF, RV-09803, SB-09803, SB-09883-S, SB-09907-S, SP-09801
B) AK-14703-J, AM-15703-J
C) AI-06210-IK, AI-7155-IK
D) AK-17702-J
E) CL-07011, CL-07024, CL-07045, CL-07065, CL-07080, CL-071165, CL-071180, CL-07511, CL-07524, CL-07545, CL-07590, CL-07611, CL-07624, CL-07635, CL-07645, CL-07665, CL-07690, CL-07700, CL-07711, CL-07724, CL-07735, CL-07745, CL-07765, CL-07780, CL-07790-R, CL-07800, CL-07824, CL-07835, CL-07845, CL-07880, CL-07924, CL-07965, CL-07980, CP-07011, CP-07511, CP-07611, CP-07711, CP-07811, CP-07911, CR-07645, CR-07745
F) SC-00001, W-15549, W-19922
G) AA-00611, AA-15511, AA-15511-S, AA-15611, AA-15611-S, AA-15624
H) PT-65509-HFC
I) PT-45509
J) CA-09801, CA-09807, MTO-09801-CHA
K) CL-08403, CL-08503, CL-08503-A, CL-08603, CL-08605, CL-08605-HF, CL-08703, CL-08705-HF, CL-08803, CP-08403, CP-08503, CP-08603, CP-08603-P, CP-08703, CP-08803, CP-08903, CW-08703, CW-08803, IC-09880
L) W20041
M) W-20267
N) CA-11142, SI-11142
O) W19910
P) W20027
Q) W20949
R) W20042
S) PT-12709-WC, PT-65709-WC
Lot or Serial #: A) Contact Manufacturer
B) Contact Manufacturer
C) Contact Manufacturer
D) Contact Manufacturer
E) Contact Manufacturer
F) Contact Manufacturer
G) Contact Manufacturer
H) Contact Manufacturer
I) Contact Manufacturer
J) Contact Manufacturer
K) Contact Manufacturer
L) Contact Manufacturer
M) Contact Manufacturer
N) Contact Manufacturer
O) Contact Manufacturer
P) Contact Manufacturer
Q) Contact Manufacturer
R) Contact Manufacturer
S) Contact Manufacturer
Reason for Recall: Material used in the manufacture of these products is not lipid resistant and could be weakened during the administration of lipid solution.

Top of Page

Manufacturer: B. Braun Medical Inc.
Recall Posting Date: 2009-04-27
Trade Name: A) IV Set with Universal Spike, 2 Ultrasite
B) Primary IV Set with 3 Ultrasite
Recall Start Date: 2009-03-27
Recall Number: 47750
Hazard Classification: Type II
Model or Catalog #: A) 352049/CSP152VSL
B) 352049, 375100
Lot or Serial #: A) 61028769, 61028767
B) 61029904, 61029908
Reason for Recall: Investigation for occlusion/no flow identified that disks involved in the low pressure check valve to have not been polyisoprene coated.

Top of Page

Manufacturer: Bard Access Systems, Inc.
Recall Posting Date: 2009-04-27
Trade Name: Wizard Replacement Gastrostomy Device
Recall Start Date: 2009-01-16
Recall Number: 46066
Hazard Classification: Type II
Model or Catalog #: 00201W, 00202W, 00204W, 00205W, 00207W, 00214W, 00215W, 00223W, 00224W
Lot or Serial #: > 10 Numbers, Contact Manufacturer
Reason for Recall: Difficulty inserting or removing the feeding adapter cannula into the device.

Top of Page

Manufacturer: Bard Peripheral Vascular, Inc.
Recall Posting Date: 2009-04-13
Trade Name: Bard Max-Core Disposable Biopsy Instr.
Recall Start Date: 2009-03-09
Recall Number: 47251
Hazard Classification: Type II
Model or Catalog #: MC1810, MC1816, MC1820
Lot or Serial #: RESH0255, RESH0057, RESH0736, RESI0279, RESI0451
Reason for Recall: Incorrect label. Label indicates a length of sample notch of 1.9cm (19mm), where actual product is 1.8cm (18mm), a potential difference of 1mm in length.

Top of Page

Manufacturer: Bard Peripheral Vascular, Inc.
Recall Posting Date: 2009-04-13
Trade Name: Truguide Coaxial Biopsy Needle
Recall Start Date: 2009-04-01
Recall Number: 47695
Hazard Classification: Type II
Model or Catalog #: C1410A, C1810B, C1813B, C1816B, C1820B, C2013B, C2016B, C2020B
Lot or Serial #: > 10 Numbers, Contact Manufacturer
Reason for Recall: Black circle on pouch label for C2013B stated "for use with Bard MaxCore or Monopty Instruments", instead of "for use with MAGNUM Instruments and Biopsy Needles or Biopty Instrument and Biopty-Cut Needles".

Top of Page

Manufacturer: Bard Peripheral Vascular, Inc.
Recall Posting Date: 2009-06-08
Trade Name: A) Vacora Vacuum Biopsy System
B) Vacora Vacuum Biopsy System - Cannula
Recall Start Date: 2009-04-14
Recall Number: 47925
Hazard Classification: Type II
Model or Catalog #: A) VC10118P
B) VC10118MR
Lot or Serial #: A) HUSA1668, HUSC1533, HUSD1075, HUSI1063, HUSG0594
B) HUSH0816, HUSI0216, HUSC1588, HUSD2647
Reason for Recall: Some Vacora 10g plastic coaxial cannulas may leave a small metal filament in the breast.

Top of Page

Manufacturer: Beckman Coulter Inc.
Recall Posting Date: 2009-04-13
Trade Name: Flow-Set Fluorospheres
Recall Start Date: 2009-03-16
Recall Number: 47347
Hazard Classification: Type II
Model or Catalog #: 6607007
Lot or Serial #: 7524003F, 7524004F, 7524005F, 7524006F
Reason for Recall: Current flow set labelling does not provide new target settings for tetra applications.

Top of Page

Manufacturer: Beckman Coulter Inc.
Recall Posting Date: 2009-04-13
Trade Name: Access Systems Total BHCG Reagent Kit
Recall Start Date: 2009-03-16
Recall Number: 47348
Hazard Classification: Type II
Model or Catalog #: 33500
Lot or Serial #: 824542, 825652
Reason for Recall: There is an increase in background relative light units (RLU) when comparing results between when a pack is first mixed/loaded and after it has settled on the instrument for 10 hours or more. This may produce a shift in results.

Top of Page

Manufacturer: Beckman Coulter Inc.
Recall Posting Date: 2009-04-13
Trade Name: Synchron System Total Bilirubin Reagent
Recall Start Date: 2009-04-06
Recall Number: 47692
Hazard Classification: Type III
Model or Catalog #: 442745, 476861
Lot or Serial #: N/A
Reason for Recall: A metabolite of naproxen, O-desmethylnaproxen, has demonstrated a positive interference with the Jendrassik-Grof method of measuring Total Bilirubin, leading to spurious elevation in Total Biliruben levels.

Top of Page

Manufacturer: Beckman Coulter Inc.
Recall Posting Date: 2009-04-13
Trade Name: Synchron Phosphorus (PHOSm) Reagent
Recall Start Date: 2009-04-06
Recall Number: 47693
Hazard Classification: Type III
Model or Catalog #: 467868
Lot or Serial #: M808353, M808354
Reason for Recall: The Phosphorus Reagent (PHOSm) may fail calibration approximately three to six days after loading on some Synchron systems.

Top of Page

Manufacturer: Beckman Coulter Inc.
Recall Posting Date: 2009-05-11
Trade Name: Synchron Systems Ammonia (AMM) Reagent
Recall Start Date: 2009-04-08
Recall Number: 47835
Hazard Classification: Type II
Model or Catalog #: 439770
Lot or Serial #: M808278
Reason for Recall: The ammonia reagent may fail calibration or cause a low shift in quality control recovery (may recover below the limits of the established range) on some Synchron systems.

Top of Page

Manufacturer: Beckman Coulter Inc.
Recall Posting Date: 2009-05-11
Trade Name: Unicel DXC 600I Synchron Access Systems
Recall Start Date: 2009-04-14
Recall Number: 47926
Hazard Classification: Type III
Model or Catalog #: A27318
Lot or Serial #: Software V.4.0, Software V.3.0
Reason for Recall: If a sample is manually loaded to the access 2I and no program is at the access 2I or DXC console, a program is sent by the LIS only to the DXC console and the sample will not be processed at the access 2I.

Top of Page

Manufacturer: Becton, Dickinson And Company
Recall Posting Date: 2009-06-22
Trade Name: BD Falcon 100X20 mm Tissue Culture
Recall Start Date: 2009-02-17
Recall Number: 47220
Hazard Classification: Type III
Model or Catalog #: N/A
Lot or Serial #: > 10 Numbers, Contact Manufactuer
Reason for Recall: Dishes containing a small crack, which may result in the leakage of cell culture media during incubation. This crack is located on the bottom of the dish along the stacking ring.

Top of Page

Manufacturer: BHM Medical Inc.
Recall Posting Date: 2009-04-27
Trade Name: A) Combi Sling
B) Combi Sling Deluxe Child
C) Combi Sling Mesh Deluxe Child
D) Combi Sling Deluxe Oversize
E) Combi Sling Mesh Deluxe Oversize
F) Combi Sling Oversize Heavy Duty
G) Combi Sling Mesh Deluxe
Recall Start Date: 2009-04-03
Recall Number: 47789
Hazard Classification: Type II
Model or Catalog #: A) 626002
B) 626002C
C) 626002C-M
D) 626003
E) 626003M
F) 626003X
G) 626002M
Lot or Serial #: A) N/A
B) N/A
C) N/A
D) N/A
E) N/A
F) N/A
G) N/A
Reason for Recall: A premature failure of the stitching at the junction of the shoulder strap and the sling body can lead to the detachment of the shoulder strap resulting in possible patient fall.

Top of Page

Manufacturer: Bio Compression Systems
Recall Posting Date: 2009-06-08
Trade Name: A) Pumps/Sequential Circulators
B) BioComfort Arm Garments
C) BioComfort Leg Garments
Recall Start Date: 2009-05-11
Recall Number: 48425
Hazard Classification: Type III
Model or Catalog #: A) SC-2004, SC-3004, SC-3008
B) GS-3035-M, GS-3035-S
C) GS-3045-H, GS-3045-L, GS-3045-M,
GS-3045-S
Lot or Serial #: A) N/A
B) N/A
C) N/A
Reason for Recall: Medical devices sold in Canada by Bio Compression Systems are not licenced in accordance with the medical devices regulations.

Top of Page

Manufacturer: Biomet Orthopedics, Inc.
Recall Posting Date: 2009-04-13
Trade Name: C2A Ringloc Acetabular System - 28 mm
Recall Start Date: 2009-03-16
Recall Number: 47389
Hazard Classification: Type II
Model or Catalog #: 12-115112(RD115112)
Lot or Serial #: All Lots
Reason for Recall: Possibility of ceramic heads fracturing with +5mm offset.

Top of Page

Manufacturer: Biotest Medical Diagnostics GMBH
Recall Posting Date: 2009-06-22
Trade Name: Erytype S RH Donor Plates
Recall Start Date: 2009-04-03
Recall Number: 49138
Hazard Classification: Type III
Model or Catalog #: 806190100
Lot or Serial #: 7839010, 7910010
Reason for Recall: One lot of Erytype S RH Donor Plates contains an error in the labelling on the foil packet. The product is correctly identified, however the product description immediately below is incorrectly stated. The outer box information is correct as well as the barcode information on the plate frames and microplate strips.

Top of Page

Manufacturer: Boston Scientific Corporation
Recall Posting Date: 2009-04-13
Trade Name: Percutaneous Combination Stent
Recall Start Date: 2009-03-23
Recall Number: 47581
Hazard Classification: Type II
Model or Catalog #: 410-111, 410-112, 410-126, 410-202,
410-203, 410-204, 410-205, 410-206, 410-207, 410-304, 410-305
Lot or Serial #: > 100 Numbers, Contact Manufacturer
Reason for Recall: During the attempted removal of the device, sutures were separated from the catheter and remained in the patient. In one instance surgical intervention was opted to remove a suture.

Top of Page

Manufacturer: Cardiac Pacemakers Incorporated
Recall Posting Date: 2009-04-27
Trade Name: A) Cognis CRT-D HE
B) Cognis CRT-D
C) Teligen ICD (VR-HE DF1)
D) Teligen ICD (DR-HE IS-1)
Recall Start Date: 2009-04-03
Recall Number: 47936
Hazard Classification: Type II
Model or Catalog #: A) N106
B) N107
C) E102
D) E110
Lot or Serial #: A) N/A
B) N/A
C) N/A
D) N/A
Reason for Recall: Right ventricular lead complications may cause additional over-sensing ,thereby increasing the probability of inappropriate therapy.

Top of Page

Manufacturer: Cardiac Pacemakers Incorporated
Recall Posting Date: 2009-05-11
Trade Name: A) Contak Renewal 4 CRT-D
B) Vitality 2 Acid
Recall Start Date: 2009-03-04
Recall Number: 47031
Hazard Classification: Type II
Model or Catalog #: A) H-190, H-197, H-199
B) T165, T167, T175, T177
Lot or Serial #: A) N/A
B) N/A
Reason for Recall: Potential for reduced ERI to EOL time in a subset of implantable defibrillators, due to degradation of a low-voltage capacitor.

Top of Page

Manufacturer: Cardiac Science Corporation
Recall Posting Date: 2009-06-08
Trade Name: Ready Kit
Recall Start Date: 2009-02-10
Recall Number: 48618
Hazard Classification: Type III
Model or Catalog #: N/A
Lot or Serial #: N/A
Reason for Recall: Ready kits, part# 5550-003, contain gloves and antiseptic wipes that are not licensed in accordance with the medical devices regulations.

Top of Page

Manufacturer: Cardinal Health 303, Inc.
Recall Posting Date: 2009-05-11
Trade Name: A) Alaris PC Unit
B) Alaris PCA Module
Recall Start Date: 2009-03-10
Recall Number: 47844
Hazard Classification: Type III
Model or Catalog #: A) 8015
B) 8120
Lot or Serial #: A) >1000 Numbers, Contact Manufacturer
B) >1000 Numbers, Contact Manufacturer
Reason for Recall: Potential risk when the Alaris PCA Module is used with the Alaris PC Unit. The Alaris PCA Module can potentially infuse above or below the intended infusion dose for a specific sequence of events.

Top of Page

Manufacturer: Coloplast A/S
Recall Posting Date: 2009-04-27
Trade Name: Philips Bougies
Recall Start Date: 2009-01-23
Recall Number: 46373
Hazard Classification: Type II
Model or Catalog #: AG55XX
Lot or Serial #: All Manufactured Between 2003-2008
Reason for Recall: Product recall due to the possibility that the device tip could break during use.

Top of Page

Manufacturer: Computerized Medical Systems
Recall Posting Date: 2009-05-11
Trade Name: Focal Software CD
Recall Start Date: 2009-04-09
Recall Number: 48015
Hazard Classification: Type II
Model or Catalog #: Focal SIM
Lot or Serial #: N/A
Reason for Recall: Setup reference point incorrectly defined for prone patients when manual shifts are used.

Top of Page

Manufacturer: Computerized Medical Systems
Recall Posting Date: 2009-06-08
Trade Name: XIO Radiation Treatment Planning System
Recall Start Date: 2009-05-05
Recall Number: 48447
Hazard Classification: Type II
Model or Catalog #: N/A
Lot or Serial #: Versions 4.3.0 to 4.40.0
Reason for Recall: When beams are renumbered, it is possible to get into a state where the dose displayed for a beam does not match the beam placement on the patient.

Top of Page

Manufacturer: Cook, Inc.
Recall Posting Date: 2009-05-25
Trade Name: A) Zenith Renu AAA Converter
B) Zenith Renu AAA Main Body
C) Zenith AAA Main Body Bifurcated Stent
Recall Start Date: 2009-03-16
Recall Number: 47349
Hazard Classification: Type II
Model or Catalog #: A) N/A
B) N/A
C) N/A
Lot or Serial #: A) All Lots
B) All Lots
C) All Lots
Reason for Recall: In rare cases the trigger wire can become damaged and then compressed between the stent and the top cap, making it difficult to remove.

Top of Page

Manufacturer: Cordis Europa N.V.
Recall Posting Date: 2009-06-08
Trade Name: Cypher Select + Sirolimus-Eluting Stent
Recall Start Date: 2009-05-08
Recall Number: 48561
Hazard Classification: Type III
Model or Catalog #: CRB08225, CRB08250, CRB08275, CRB08300, CRB08350, CRB13225, CRB13250, CRB13275, CRB13300, CRB13350, CRB18225, CRB18250, CRB18275, CRB18300, CRB18350, CRB23225, CRB23250, CRB23275, CRB23300, CRB23350, CRB28225, CRB28250, CRB28275, CRB28300, CRB28350, CRB33225, CRB33250, CRB33275, CRB33300, CRB33350
Lot or Serial #: >100 Lots, Contact Manufacturer
Reason for Recall: In response to an increased number of complaints of cracks in the balloon inflation port hub of this coronary stent, a field safety notice has been issued to remind users to follow inspection and preparation steps.

Top of Page

Manufacturer: Data Innovations
Recall Posting Date: 2009-06-22
Trade Name: Instrument Manager
Recall Start Date: 2009-05-11
Recall Number: 48997
Hazard Classification: Type II
Model or Catalog #: IM-B02V8.06, IM-B02V8.07, IM-B02V8.08,
IM-B02V8.09
Lot or Serial #: N/A
Reason for Recall: The previous results retrieved from the specimen management database, which may be used by rules, may not be the most recent previous version.

Top of Page

Manufacturer: Dentsply Tulsa Dental Specialties
Trading As Dentsply Endodontics
Recall Posting Date: 2009-04-13
Trade Name: GT Series X
Recall Start Date: 2009-03-30
Recall Number: 47759
Hazard Classification: Type III
Model or Catalog #: SXR0602021, SXR0602025
Lot or Serial #: 073008100, 062608322
Reason for Recall: 25mm length files were mislabeled as 21mm (SXR0602021), and 21mm length files were mislabeled as 25 mm (SXR0602025).

Top of Page

Manufacturer: Dentsply Tulsa Dental Specialties
Trading As Dentsply Endodontics
Recall Posting Date: 2009-05-11
Trade Name: Proultra Surgical Endo Tip
Recall Start Date: 2009-04-06
Recall Number: 48008
Hazard Classification: Type III
Model or Catalog #: PUSURG1
Lot or Serial #: 121808304
Reason for Recall: Prototype tips were mistakenly distributed to customers.

Top of Page

Manufacturer: Depuy Orthpaedics, Inc.
Recall Posting Date: 2009-06-22
Trade Name: PFC Sigma CR Non-Porous Left Femoral
Recall Start Date: 2009-05-29
Recall Number: 48935
Hazard Classification: Type II
Model or Catalog #: 960005
Lot or Serial #: 2843263, 2869123, 2845534, 2845530, 2844799, 2952392, 2852394, 2842528, 2844381, 2843270, 2843268
Reason for Recall: A small number of PFC Sigma Cruciate Retaining Non-Porous size 5 left femoral cemented components within the affected lots have been identified as having a microscopic crack on the lateral side of the condyle in the posterior chamfer region. Microscopic cracks have the potential to affect the performance of the implant.

Top of Page

Manufacturer: Disetronic Medical Systems AG
Recall Posting Date: 2009-05-25
Trade Name: Accu-Chek Spirit Insulin Pump
Recall Start Date: 2009-04-17
Recall Number: 48163
Hazard Classification: Type II
Model or Catalog #: 04540492001, 04759702001, 04759729001
Lot or Serial #: SN02053575 to SN10006093
Reason for Recall: The insulin pump (numbers SN02053575 - SN10006093) may fail. This failure may present an intermittent or complete loss of function of the up and/or down buttons and in turn affect the desired pump operation.

Top of Page

Manufacturer: Ethicon Endo-Surgery, LLC
Recall Posting Date: 2009-05-11
Trade Name: A) Endopath Endoscopic Linear Cutters
B) Endopath Endoscopic Linear Cutters
C) Endopath Endoscopic Linear Cutters
Recall Start Date: 2009-04-08
Recall Number: 47966
Hazard Classification: Type II
Model or Catalog #: A) LONG45A
B) ATB45, ATW45
C) NAW45
Lot or Serial #: A) E4MM23, E4MP4A, E4MT4Y
B) E4MH2L, E4MG9M, E4ML6J, E4MH18
C) E4MJ3K, F4MX8C, F4N799
Reason for Recall: The mechanism which connects the articulation joint to the device shaft may be insufficient. This may cause the jaws of some of the affected Endoscopic Linear Cutters to remain closed and clamped down on tissue.

Top of Page

Manufacturer: Fisher Diagnostics, A Division Of Fisher Scientific CO, LLC
Recall Posting Date: 2009-05-11
Trade Name: Infinity Glucose Hexokinase Reagent
Recall Start Date: 2009-04-09
Recall Number: 47989
Hazard Classification: Type II
Model or Catalog #: TR15498
Lot or Serial #: V28015
Reason for Recall: Failure of product to meet the stated performance specifications for shelf life, resulting in linearity of less than the stated specifications.

Top of Page

Manufacturer: GE Healthcare
Recall Posting Date: 2009-06-08
Trade Name: AW Volumeshare2 - Software Options
Recall Start Date: 2009-04-21
Recall Number: 45984
Hazard Classification: Type II
Model or Catalog #: B79011MA
Lot or Serial #: S/N'S 96090GE6, 96091GE4, 98606GE7, 98607GE5, 98608GE3
Reason for Recall: Under certain conditions, the series could be incorrectly labelled in image view, which could lead to under-treatment of a tumour.

Top of Page

Manufacturer: GE Healthcare
Recall Posting Date: 2009-06-22
Trade Name: Compax 40E Table
Recall Start Date: 2009-02-18
Recall Number: 45258
Hazard Classification: Type II
Model or Catalog #: N/A
Lot or Serial #: > 10 Numbers, Contact Manufactuer
Reason for Recall: Table locks may not actuate, causing tabletop to unexpectedly float in either of the following axes: 1) lateral axes, 2) bidirectional (longitudinal and lateral) axes, which could injure patient or user.

Top of Page

Manufacturer: GE Healthcare
Recall Posting Date: 2009-06-22
Trade Name: Muse Cardiology Information System
Recall Start Date: 2009-03-04
Recall Number: 46833
Hazard Classification: Type II
Model or Catalog #: MUSESW7-XXXXXXXX
Lot or Serial #: > 10 Numbers, Contact Manufactuer
Reason for Recall: Stored and printed records may contain incorrect information when records containing default patient identifiers (PID) are confirmed as valid PID's in Muse Cardiology Information Systems versions 7.0, 7.01, 7.0.2, 7.1 & 7.1.1

Top of Page

Manufacturer: GE Healthcare
Recall Posting Date: 2009-06-22
Trade Name: CIC Pro Clinical Information Center
Recall Start Date: 2009-02-19
Recall Number: 46853
Hazard Classification: Type II
Model or Catalog #: CIC-XXXX-XXXXX-XXXXX*
Lot or Serial #: S/N'S SDY09020430GA & SDY09030443GA
Reason for Recall: Circuit board supplied by 3rd party for MP 100 hardware platform for CIC Pro version 5.1 software may fail and result in potential loss of monitoring and inability to power up after powering down of CIC Pro.

Top of Page

Manufacturer: GE Healthcare
Recall Posting Date: 2009-06-22
Trade Name: 1.5T Signa Infinity MR Excite - System
Recall Start Date: 2009-05-11
Recall Number: 47837
Hazard Classification: Type II
Model or Catalog #: 2294302, M3000CB
Lot or Serial #: > 10 Numbers, Contact Manufactuer
Reason for Recall: An error in the coding of the 11.1_M4_0818A version of software can result in images being flipped under very limited and specific conditions.

Top of Page

Manufacturer: GE Medical Systems Information Technologies
Recall Posting Date: 2009-06-22
Trade Name: Carescape V100
Recall Start Date: 2009-02-09
Recall Number: 46236
Hazard Classification: Type II
Model or Catalog #: V100-QBAA-CXAA-XX
Lot or Serial #: > 10 Numbers, Contact Manufactuer
Reason for Recall: The alarm and pulse volume indicators are inverted on the label of french language units.

Top of Page

Manufacturer: Getinge Disinfection AB
Recall Posting Date: 2009-05-11
Trade Name: Washer Didinfector Getinge 9027 - 9100
Recall Start Date: 2009-04-20
Recall Number: 48035
Hazard Classification: Type II
Model or Catalog #: 9027, 9100
Lot or Serial #: N/A
Reason for Recall: The frame earth of the supply transformers for Getinge 9100 and 9027-series Washer Disinfector have burnt out. Result from investigation shows poor connection between incoming and outgoing Protective Earth.

Top of Page

Manufacturer: Getinge Disinfection AB
Recall Posting Date: 2009-06-22
Trade Name: Washer Disinfectors With Transformer
Recall Start Date: 2009-04-24
Recall Number: 48035
Hazard Classification: Type II
Model or Catalog #: 9027, 9100
Lot or Serial #: > 10 Numbers, Contact Manufactuer
Reason for Recall: The frame earth of the supply transformers for the Getinge 9100-series Washer Disinfector have burnt out on one installation in Australia.

Top of Page

Manufacturer: Haemonetics Corporation
Recall Posting Date: 2009-04-27
Trade Name: List No. 620 PCS2 Harness Set
Recall Start Date: 2009-04-13
Recall Number: 47918
Hazard Classification: Type III
Model or Catalog #: 00620-00
Lot or Serial #: LN 081219511 and 081219512, LN 081222510 and 081222511,
LN 081223510 and 081223511, LN 081224510 to 081224512
Reason for Recall: This recall is the result of reports of leaks at the blood filter of the Haemonetics lN620 PCS2 Plasma Harness Set.

Top of Page

Manufacturer: Hill-ROM Company, Inc.
Recall Posting Date: 2009-04-13
Trade Name: Hill ROM Totalcare Bed
Recall Start Date: 2009-03-09
Recall Number: 47219
Hazard Classification: Type II
Model or Catalog #: N/A
Lot or Serial #: J329AMXXX to J340AM1369
Reason for Recall: E-ring may not fully be seated on the siderail bracket. It could cause the e-ring to be missing and could result in an inability to latch the siderail.

Top of Page

Manufacturer: Hologic, Inc.
Recall Posting Date: 2009-05-11
Trade Name: A) Discovery X-Ray Bone Densitometer
B) Explorer X-Ray Bone Densitometer
Recall Start Date: 2009-04-17
Recall Number: 47998
Hazard Classification: Type II
Model or Catalog #: A) DISCOVERY-A, DISCOVERY-C, DISCOVERY-CI, DISCOVERY-W, DISCOVERY-WI
B) EXPLORER
Lot or Serial #: A) S/N: 83232, 83336, 83760, 83792, 83024, 82888, 83053, 83318, 83576
B) SN 91129
Reason for Recall: In rare instances, the system does not turn the x-rays off at the end of a DXA scan. The "x-ray on" indicator light remains on, but an audible signal and the computer screen indicate the x-ray is off.

Top of Page

Manufacturer: Howmedica Osteonics - Stryker Ireland
Recall Posting Date: 2009-04-13
Trade Name: Restoration Modular Cone Bodies
Recall Start Date: 2009-03-27
Recall Number: 47576
Hazard Classification: Type II
Model or Catalog #: 6276-1-121, 6276-1-125, 6276-1-219, 6276-1-325
Lot or Serial #: 22125701, 21834602, 21883201, 21883401
Reason for Recall: Packaging test logs indicate burst test results fell below validation parameters. There may be deterioration of short or long term packaging integrity (inner or outer) with potential loss of sterility.

Top of Page

Manufacturer: Howmedica Osteonics - Stryker Ireland
Recall Posting Date: 2009-05-25
Trade Name: Austin Moore Stems - Curved 43 mm
Recall Start Date: 2009-04-27
Recall Number: 48207
Hazard Classification: Type II
Model or Catalog #: 6939-0-430
Lot or Serial #: LOIINRA
Reason for Recall: A size 43mm Austin Moore endoprosthesis curved stem was found packaged as a size 45mm stem.

Top of Page

Manufacturer: Howmedica Osteonics Corporation
Recall Posting Date: 2009-05-25
Trade Name: Triathlon Offset Adaptor Trials
Recall Start Date: 2009-04-22
Recall Number: 48074
Hazard Classification: Type III
Model or Catalog #: 5570-T-020, 5570-T-040, 5570-T-060, 5570-T-080
Lot or Serial #: N/A
Reason for Recall: Advisory reiterating to customers the potential for the adaptor trial to seize, the preventive maintenance measures, and risk mitigation measures, as stated in the package insert.

Top of Page

Manufacturer: Immucor Inc.
Recall Posting Date: 2009-05-11
Trade Name: Gallileo Echo Blood Bank Analyzer
Recall Start Date: 2009-04-02
Recall Number: 47888
Hazard Classification: Type II
Model or Catalog #: 87000
Lot or Serial #: N/A
Reason for Recall: Incorrect patient demographic information could be associated with a sample ID. This only occurs when manually ordering an assay using the run test wizard on instrument with bi-directional interface capability.

Top of Page

Manufacturer: Immucor Inc.
Recall Posting Date: 2009-06-08
Trade Name: Galileo Echo Blood Bank Analyzer
Recall Start Date: 2009-04-27
Recall Number: 48195
Hazard Classification: Type II
Model or Catalog #: 87000
Lot or Serial #: N/A
Reason for Recall: Improvements of Echo software since the 1.1.2.28.1, to address the recalls previously initiated: duplicate alphabetical sample barcodes, information for instruments interfaced to laboratory information system.

Top of Page

Manufacturer: J T Posey Co.
Recall Posting Date: 2009-06-22
Trade Name: Posey Buckle
Recall Start Date: 2009-05-29
Recall Number: 48899
Hazard Classification: Type III
Model or Catalog #: N/A
Lot or Serial #: 235018, 235036, S27947, S27957
Reason for Recall: Product made with incorrect buckle, potential for failure.

Top of Page

Manufacturer: Kaltenbach & Voight GMBH
Recall Posting Date: 2009-05-11
Trade Name: Eccentric Bushes
Recall Start Date: 2009-01-18
Recall Number: 47039
Hazard Classification: Type III
Model or Catalog #: 0.535.4692
Lot or Serial #: N/A
Reason for Recall: A nonconformance with the Eccentric Bushes can result in a rough surface that will result in altered revolutions per minute(RPM) and the lifetime of the device.

Top of Page

Manufacturer: Leckey (James Leckey Design)
Recall Posting Date: 2009-05-11
Trade Name: Leckey Four-Point Pelvic Harness
Recall Start Date: 2009-04-15
Recall Number: 47922
Hazard Classification: Type II
Model or Catalog #: 122-719
Lot or Serial #: LEC/019910-LEC/043681
Reason for Recall: The central plastic buckle degrades and can fail in use. The belts are used in the James Leckey seating systems: mobile advance seat, contoured advance seat, squiggles early sitting system, squiggles saddle seat.

Top of Page

Manufacturer: Maquet Critical Care AB
Recall Posting Date: 2009-04-13
Trade Name: Servo 300
Recall Start Date: 2009-03-27
Recall Number: 47623
Hazard Classification: Type II
Model or Catalog #: 6079300, 6079391, 6079433, 6150614, 6424704, 6424779
Lot or Serial #: > 10 Numbers, Contact Manufacturer
Reason for Recall: Printed circuit boards have stopped working, results in expiratory valve staying in the open position, sometimes preceded by a short valve closure. Remote hazard of serious adverse health consequences.

Top of Page

Manufacturer: Mediland Enterprise Corporation
Recall Posting Date: 2009-06-22
Trade Name: ASC 2000 Ambulatory Surgical Table
Recall Start Date: 2009-04-17
Recall Number: 48613
Hazard Classification: Type III
Model or Catalog #: MTS110003
Lot or Serial #: 07160407V3.01, 043600401V200, 043600402V200, 041600323V200, 045100705V300, 061400907V3.00, 061406905V300
Reason for Recall: Repetitive rubbing of the hydraulic hoses against the interior of the stainless steel shroud may result in the rupture of the hydraulic hosing causing loss of control of the table surface.

Top of Page

Manufacturer: Medi-Tech Boston Scientific Corporation
Recall Posting Date: 2009-06-22
Trade Name: A) Wiseguide Guide Catheter Femoral
B) Wiseguide Guide Catheter Allright
C) Wiseguide Guide Catheter Voda
D) Wiseguide Guide Catheter Amplatz
E) Wiseguide Guide Catheter Bypass
F) Wiseguide Guide Catheter Multipurpose
G) Wiseguide Guide Catheter Radial
H) Wiseguide Guide Catheter Kimny
Recall Start Date: 2009-03-13
Recall Number: 47359
Hazard Classification: Type III
Model or Catalog #: A) 16320-02, 19500-02, 19500-29, 19815-92, H74919815520
B) 19815-501
C) 16320-72, 16320-78, 19500-71, 19500-72, 19500-73, 19500-74, 19500-77, 19500-78, 19815-71, 19815-72, 19815-73, 19815-74
D) 16320-17, 16320-18, 16320-20, 16320-21, 19500-20, 19500-21, 19500-22
E) 19815-446
F) 16320-141, 19500-39, 19815-41
G) 19815-554
H) 19815-583
Lot or Serial #: A) H74916320021, H74919500020, H74919500290, H74919815920
B) H749198155010
C) H74916320721, H74916320781, H74919500710, H74919500720, H74919500730, H74919500740, H74919500770, H74919500780, H74919815710, H74919815720, H74919815730, H74919815740
D) H74916320171, H74916320181, H74916320201, H74916320211, H74919500210, H74919500220,
E) H749198154460
F) H749163201411, H74919500390, H74919815410
G) H749198155540
H) H749198155830
Reason for Recall: Difficulties in connecting the product hubs with the Y-adaptors and toughy borst connectors. Product out of specs with thread outer diameters.

Top of Page

Manufacturer: Medline Industries Inc.
Recall Posting Date: 2009-05-25
Trade Name: Medline Penrose Drain
Recall Start Date: 2009-04-21
Recall Number: 48072
Hazard Classification: Type II
Model or Catalog #: DYND50420, DYND50421, DYND50422, DYND50423, DYND50424, DYND50425, DYND50426
Lot or Serial #: 05AA0001-09CA9999
Reason for Recall: A drain placed by a surgeon and an x-ray ordered, the drain did not show up on x-ray although the packaging states the product is x-ray opaque. Two lots of product are affected in this issue.

Top of Page

Manufacturer: Medmont PTY Ltd.
Recall Posting Date: 2009-05-11
Trade Name: A) E300 Corneal Topographer
B) DV2000 Digital Imaging Software
C) M700 Automated Perimeter
Recall Start Date: 2009-03-10
Recall Number: 45746
Hazard Classification: Type II
Model or Catalog #: A) N/A
B) N/A
C) M700
Lot or Serial #: A) >10 Numbers, Contact Manufacturer
B) >10 Numbers, Contact Manufacturer
C) >10 Numbers, Contact Manufacturer
Reason for Recall: Unlicensed class II medical device.

Top of Page

Manufacturer: Medovations Inc.
Recall Posting Date: 2009-06-08
Trade Name: Insufflation Tubing With Filter
Recall Start Date: 2009-05-14
Recall Number: 48488
Hazard Classification: Type II
Model or Catalog #: SU1101
Lot or Serial #: 209296
Reason for Recall: The device, model SU1101, is not licensed for sale in Canada. It is however the same product in specifications and materials as JA-1101, which is licensed for sale in Canada.

Top of Page

Manufacturer: Medtronic Inc.
Recall Posting Date: 2009-06-08
Trade Name: A) Sigma Pacemaker System
B) Kappa 600 KDR Series Pacemakers
C) Kappa 700 KDR Series Pacemakers
D) Kappa 700 KD Series Pacemakers
E) Kappa 700 KSR Series Pacemakers
F) Kappa 900 KSR Series Pacemakers
Recall Start Date: 2009-05-18
Recall Number: 48540
Hazard Classification: Type I
Model or Catalog #: A) SD203, SD303, SDR203, SDR303, SDR306, SS106, SS203, SS303, SSR203, SSR303, SSR306, SVDD303, SVVI103
B) KDR603
C) KDR703, KDR706, KDR721
D) KD701, KD703, KD706
E) KSR701, KSR703, KSR706
F) KSR903
Lot or Serial #: A) >100 Lots, Contact Manufacturer
B) PHH620224S, PHH620227S
C) PGY623319S, PGY623323S, PGY623355S, PGW621053S, PGR625317S, PGR625959S
D) >10 Lots, Contact Manufacturer
E) >1000 Lots, Contact Manufacturer
F) >100 Lots, Contact Manufacturer
Reason for Recall: The pacemakers may fail at a higher than expected rate due to separation of wires that connect the electronic circuit to other pacemaker components (e.g. battery, connector). This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.

Top of Page

Manufacturer: Medtronic Inc.
Recall Posting Date: 2009-06-08
Trade Name: Sigma Pacemaker System
Recall Start Date: 2009-05-18
Recall Number: 48702
Hazard Classification: Type I
Model or Catalog #: SD203, SD303, SDR203, SDR303, SDR306, SS106, SS203, SS303, SSR203, SSR303, SSR306, SVDD303, SVVI103
Lot or Serial #: >1000 Lots, Contact Manufacturer
Reason for Recall: This is an update of performance and patient management recommendations for a subset of Sigma pacemakers previously recalled because of an increased rate of failure associated with interconnect wire separation caused by a particular cleaning solvent used in manufacturing.

Top of Page

Manufacturer: Medxl Inc.
Recall Posting Date: 2009-04-13
Trade Name: A) Heparin pre-filled syringes
B) Saline pre-filled syringes
Recall Start Date: 2009-03-29
Recall Number: 47632
Hazard Classification: Type II
Model or Catalog #: A) 3706, 3780, 3781, 3786, 3787
B) 3704, 37043, 37043B, 37043BNC, 3705C, 3705NC, 3706
Lot or Serial #: A) All lots between 6892 and 8180
B) All lots between 6892 and 8180
Reason for Recall: Complaints received about discolouration and particulate matter contamination.

Top of Page

Manufacturer: Merit Medical Systems Inc.
Recall Posting Date: 2009-06-22
Trade Name: Prelude Short Sheath Introducer
Recall Start Date: 2009-04-20
Recall Number: 48882
Hazard Classification: Type II
Model or Catalog #: PSS-5F-4-018MT, PSS-5F-4-038MT, PSS-5F-4MT, PSS-6F-4-018MT, PSS-6F-4MT, PSS-7F-4MT, PSS-8F-4MT
Lot or Serial #: N/A
Reason for Recall: The sidearm tubing may detach from the sheath during use. If this failure occurs, it may result in excessive patient blood loss and/or risk of blood-borne pathogen exposure to those in the surrounding area.

Top of Page

Manufacturer: Motion Concepts LP
Recall Posting Date: 2009-05-25
Trade Name: A) Tilt/Elevating Seating System
B) Tilt/Elevate/Recline Seating System
Recall Start Date: 2009-02-19
Recall Number: 46283
Hazard Classification: Type II
Model or Catalog #: A) N/A
B) N/A
Lot or Serial #: A) >10 Numbers, Contact Manufacturer
B) >10 Numbers, Contact Manufacturer
Reason for Recall: Possibility of stress related cracks occurring in our power elevating seat actuator models as the result of atypical or extreme usage of the wheelchair seating system.

Top of Page

Manufacturer: Norwex Enviro Products Inc.
Recall Posting Date: 2009-04-13
Trade Name: Norwex Silvercare Toothbrush
Recall Start Date: 2009-03-17
Recall Number: 47238
Hazard Classification: Type II
Model or Catalog #: 22963
Lot or Serial #: N/A
Reason for Recall: Toothbrush head may pose a choking or swallowing hazard to children under three years of age or to individuals that would normally require supervision or assistance brushing their teeth.

Top of Page

Manufacturer: Ormco Corporation
Recall Posting Date: 2009-05-25
Trade Name: Orthos CM Bracket
Recall Start Date: 2009-02-13
Recall Number: 46601
Hazard Classification: Type III
Model or Catalog #: 454-0210, 454-1210
Lot or Serial #: 08H599H, 08H358H, 08J174J, 08J175J
Reason for Recall: Orthos CM Brackets are incorrectly labelled +9 degrees, but they have a torque of -9. Attachment will result in significant delay in treatment.

Top of Page

Manufacturer: Ortho-Clinical Diagnostics Inc.
Recall Posting Date: 2009-04-13
Trade Name: A) Vitros Chemistry Slides - Creatine
B) Vitros Chemistry Slides - Enzymatic CO2
C) Vitros Chemistry Slides - CSF Protein
D) Vitros Chemistry Slides - Total Bilirubin
Recall Start Date: 2009-03-31
Recall Number: 47712
Hazard Classification: Type III
Model or Catalog #: A) 680 2584
B) 8262396
C) 8208431
D) 8159931
Lot or Serial #
Reason for Recall: The foil wrapper for specific lots of slide cartridges may have been damaged during the packaging process. Exposure of slides to uncontrolled environmental conditions could impact performance.

Top of Page

Manufacturer: Ortho-Clinical Diagnostics Inc.
Recall Posting Date: 2009-06-22
Trade Name: A) Vitros 3600 Immunodiagnostic Software
B) Vitros 5600 Integrated System Software
Recall Start Date: 2009-05-28
Recall Number: 48864
Hazard Classification: Type II
Model or Catalog #: A) 680 2865
B) 680 2863
Lot or Serial #: A) 36000116, 36000130
B) 56000193, 56000298, 56000124, 56000136, 56000336, 56000337
Reason for Recall: Complaint received of a biassed glucose result on a Vitros 5600 Integrated System. Investigation has found that under a very specific set of circumstances, when the display/report screen is configured by the operator, an erroneous result could also be generated by the Vitros 3600 Immunodiagnostic System.

Top of Page

Manufacturer: Philips Medical Systems
Recall Posting Date: 2009-04-27
Trade Name: Holter
Recall Start Date: 2009-03-30
Recall Number: 47704
Hazard Classification: Type II
Model or Catalog #: 1810, 2010+
Lot or Serial #: N/A
Reason for Recall: Holter software version 2.9 and 2.9.1 may contain problems which could affect its performance.

Top of Page

Manufacturer: Philips Medical Systems
Recall Posting Date: 2009-04-27
Trade Name: Heartstart XL
Recall Start Date: 2009-04-09
Recall Number: 47915
Hazard Classification: Type II
Model or Catalog #: M4735A
Lot or Serial #: S/N US00442485 to US00469873
Reason for Recall: The rotary energy switch may fail and prevent the user from turning the device on, rendering it unusable for monitoring and defibrillation therapy. The failure may also occur by spontaneously powering on.

Top of Page

Manufacturer: Philips Medical Systems
Recall Posting Date: 2009-04-27
Trade Name: Heartstart MRX Defibrillator / Monitor
Recall Start Date: 2009-04-09
Recall Number: 47916
Hazard Classification: Type II
Model or Catalog #: M3535A, M3536A
Lot or Serial #: S/N US00210406 TO US00333123
Reason for Recall: The therapy switch has a small potential to fail. Most likely failure mode is spontaneous turn-on which could deplete the battery, rendering the device unstable until power is restored.

Top of Page

Manufacturer: Philips Medical Systems (Cleveland), Inc.
Recall Posting Date: 2009-06-22
Trade Name: Brilliance 6/10/16 Slice CT-SFRTWR Dent
Recall Start Date: 2009-06-10
Recall Number: 49151
Hazard Classification: Type II
Model or Catalog #: 455011202691
Lot or Serial #: N/A
Reason for Recall: 1. When images are saved or filmed that contain the curved multi_planar reformation section (CMPRS) while using the dental application v4.0.0 to v4.0.1.9999 on the extended brilliance workspace, the right/left annotations will be reversed on views that were created with a short curve.

Top of Page

Manufacturer: Philips Medical Systems Nederland B.V.
Recall Posting Date: 2009-06-22
Trade Name: A) Multidiagnost Eleva-Flat Detector
B) Allura XPER FD10/10-Main Unit
Recall Start Date: 2009-05-15
Recall Number: 48595
Hazard Classification: Type II
Model or Catalog #: A) 70834
B) ALLURA XPER FD10/10
Lot or Serial #: A) N/A
B) N/A
Reason for Recall: The system may shut down and not restart due to a manufacturing error in the printed circuit board in the main-cabinet.

Top of Page

Manufacturer: Philips Medical Systems Nederland B.V.
Recall Posting Date: 2009-06-22
Trade Name: A) Integris V5000/BV5000
B) Integris H5000F Cardiology Imaging System
C) Integris H5000C Cardiology Imaging System
D) Integris BH5000 Cardiology Imaging System
E) Integris Allura
F) Allura XPER FD10
G) Integris H1000
H) Integris H3000
I) Integris V3000
Recall Start Date: 2009-05-12
Recall Number: 49048
Hazard Classification: Type II
Model or Catalog #: A) 722041*, 722042*
B) 722017
C) 722016
D) 722021
E) 722043*, 722044*
F) ALLURA XPER FD10
G) N/A
H) N/A
I) N/A
Lot or Serial #: A) N/A
B) N/A
C) N/A
D) N/A
E) N/A
F) N/A
G) N/A
H) N/A
I) N/A
Reason for Recall: A partial grid switch failure may occur in Allura XPER and Integris systems that may result in a higher x-ray dose than expected. This issue may pose a risk for patients or users. The potential failure can lead to a radiation exposure rate in excess of the 11.5 R/min Health Canada requirement. However, it will only occur if the grid switch fails during fluoroscopy examinations using high KV values.

Top of Page

Manufacturer: Philips Medical Systems Nederland B.V.
Recall Posting Date: 2009-06-22
Trade Name: A) Achieva 3.0T MRI System-Main Unit
B) Achieva 1.5T MRI System-Main Unit
Recall Start Date: 2009-06-09
Recall Number: 49149
Hazard Classification: Type II
Model or Catalog #: A) ACHIEVA 3.0T
B) ACHIEVA 1.5T
Lot or Serial #: A) N/A
B) N/A
Reason for Recall: The affected MR accessory carts may contain magnetic material and can therefore be attracted to the magnet.

Top of Page

Manufacturer: Philips Medizin Systeme Boeblingen GMBH
Recall Posting Date: 2009-06-22
Trade Name: Intellivue MP70 Patient Monitor System
Recall Start Date: 2009-05-22
Recall Number: 48839
Hazard Classification: Type II
Model or Catalog #: M8007A
Lot or Serial #: N/A
Reason for Recall: If scheduled orders are documented and edited prior to the orders' original schedule time, Carevue Chart Release C.0 (running on the DC7100 computers of the Intellivue MP700 patient monitor system) can create a second instance of the same order marked as pending, if the following conditions occur:
1. An order or intervention is entered as a scheduled administration and
2. A clinician charts the pending order earlier than scheduled and
3. A user/clinician changes, edits or acknowledges the

Top of Page

Manufacturer: Philips Medizin Systeme Boeblingen GMBH
Recall Posting Date: 2009-06-22
Trade Name: A) Avalon Fetal Monitor FM30-Main Unit
B) Avalon Fetal Monitor FM20-Main Unit
Recall Start Date: 2009-06-09
Recall Number: 49150
Hazard Classification: Type II
Model or Catalog #: A) M2703A
B) M2702A
Lot or Serial #: A) DE53001002 Through DE53107383
B) DE53001002 Through DE53107383
Reason for Recall: This problem affects revision C and D of the software. In rare circumstances, the settings for paper scale type and recorder speed may revert back to the factory default settings, which are: USA paper style and 3 cm/min paper speed. This behaviour would have the most impact in Europe and Asia/Pacific where other settings are preferred. If this change remains undetected by the user, it may lead to misinterpretation of the fetal trace and potential incorrect clinical decisions regarding patient care. The problem occurs when the power-up/boot sequence of the fetal monitor is interrupted, e.g. switching the monitor off or unplugging the power cord before it has completed the boot sequence and switching it on again immediately (within 60 sec) after the interruption.

Top of Page

Manufacturer: Physio-Control, Inc.
Recall Posting Date: 2009-05-11
Trade Name: Lifepak 12 Defibrillator / Monitor
Recall Start Date: 2009-04-09
Recall Number: 48000
Hazard Classification: Type II
Model or Catalog #: LP 12
Lot or Serial #: >10 Numbers, Contact Manufacturer
Reason for Recall: Affected defibrillator /monitors may have a solder defect on the H bridge component that could prevent the device from providing a defibrillation shock.

Top of Page

Manufacturer: Physio-Control, Inc.
Recall Posting Date: 2009-06-08
Trade Name: Lifepak 9/9P Internal Paddles & Handles
Recall Start Date: 2009-02-17
Recall Number: 48161
Hazard Classification: Type II
Model or Catalog #: 11130-0000XX, 11131-0000XX, 800441-XX, 802154-XX
Lot or Serial #: > 10, Contact Manufacturer
Reason for Recall: Sterilization efficacy for the current labelled methods cannot be confirmed. These Lifepak 9/9P internal defibrillation handles without discharge control & custom-mated paddles, were discontinued in August 2008.

Top of Page

Manufacturer: Picis Inc.
Recall Posting Date: 2009-06-22
Trade Name: A) Picis OR Manager
B) Picis Preop Manager
C) Picis Anesthesia Manager
D) Picis PACU Manager
E) Picis Critical Care Manager
Recall Start Date: 2009-04-08
Recall Number: 48937
Hazard Classification: Type II
Model or Catalog #: A) model/catalog # 4235
B) model/catalog # 4250
C) model/catalog # 4220
D) model/catalog # 4245
E) model/catalog # 1110
Lot or Serial #: A) N/A
B) N/A
C) N/A
D) N/A
E) N/A
Reason for Recall: If not properly configured, software will allow patient allergy and precaution data to be overwritten with automatic updates from the hospital information system (HIS). This can result in deletion of allergy information.

Top of Page

Manufacturer: Premier Dental Products Company
DBA Premier Medical
Recall Posting Date: 2009-05-11
Trade Name: Integra CEM
Recall Start Date: 2009-03-25
Recall Number: 48059
Hazard Classification: Type II
Model or Catalog #: 3001410
Lot or Serial #: All Lots
Reason for Recall: Sale or distribution of the Integra CEM (item #3001410) is in violation of the medical devices regulations. The Integra CEM is not licensed as required per section 26 of the medical devices regulations.

Top of Page

Manufacturer: R & D Systems, Inc.
Recall Posting Date: 2009-06-08
Trade Name: Human STFR Quantikine IVD Kit
Recall Start Date: 2009-03-03
Recall Number: 48601
Hazard Classification: Type II
Model or Catalog #: N/A
Lot or Serial #: 259416, 261514, 262759
Reason for Recall: During manufacturing, it was found the standard used to calibrate the assay, may have evaporated in some vials. If evaporation occurs this will cause the standards to read erroneously.

Top of Page

Manufacturer: R & D Systems, Inc.
Recall Posting Date: 2009-06-08
Trade Name: Quantikine IVD Human B2-Microglobulin
Recall Start Date: 2009-03-04
Recall Number: 48674
Hazard Classification: Type II
Model or Catalog #: N/A
Lot or Serial #: 260980
Reason for Recall: During manufacturing, it was found the standard used to calibrate the assay, may have evaporated in some vials. If evaporation occurs this will cause the standards to read erroneously.

Top of Page

Manufacturer: Radiometer Medical APS
Recall Posting Date: 2009-05-25
Trade Name: Waste Bottle For ABL7XX And 8XX Flex
Recall Start Date: 2009-04-30
Recall Number: 48225
Hazard Classification: Type II
Model or Catalog #: D512 (905-590), D513 (905-802)
Lot or Serial #: For 905-590/D512 : WR-01, WR-02, WR-03, WS-01, WS-02, WS-03, WU-02, WU-03
For 905-802/D513 : WR-01, WR-02, WR-03, WR-04, WS-01, WS-02, WS-03, WS-04, WU-01, WU-02, WU-03, WU-04, WU-05, WU-06, WY-01
Reason for Recall: When removing the waste bottle from the analyzer, waste material may leak both from the analyzer and from the waste bottle. This leakage is due to clogged vent holes creating over pressure in the bottle.

Top of Page

Manufacturer: Resmed Paris
Recall Posting Date: 2009-06-22
Trade Name: VS Ventilator
Recall Start Date: 2009-06-01
Recall Number: 48885
Hazard Classification: Type III
Model or Catalog #: N/A
Lot or Serial #: VSU0802002, VSU0802003, VSU0802001, VSU0711510
Reason for Recall: Resmed received a report of a failure of a VS Ventilator in Japan that had resulted in a failure of ventilation at start-up. It occurred within a hospital environment.

Top of Page

Manufacturer: Respironics Inc.
Recall Posting Date: 2009-05-11
Trade Name: SmartMonitor 2 Infant Apnea Monitor
Recall Start Date: 2009-04-27
Recall Number: 48114
Hazard Classification: Type II
Model or Catalog #: 4002, 4003
Lot or Serial #: S/N: 3000033364 to 3000038740
Reason for Recall: A variation in the monitor manufacturing process could expose wires to potential short circuit of the wire leading to the alarm module. This can result in a situation where the alarm will not sound.

Top of Page

Manufacturer: Respironics Inc.
Recall Posting Date: 2009-06-08
Trade Name: SmartMonitor 2 Infant Apnea Monitor
Updated recall # 48114 previously posted on 2009-05-11. / Mise à jour du retrait # 48114 affliché le 2009-05-11.
Recall Start Date: 2009-04-27
Recall Number: 48114
Hazard Classification: Type I
Model or Catalog #: 4002, 4003
Lot or Serial #: S/N: 3000033364 to 3000038740
Reason for Recall: A variation in the monitor manufacturing process could expose wires to potential short circuit of the wire leading to the alarm module. This can result in a situation where the alarm will not sound.

Top of Page

Manufacturer: Roche Diagnostics GMBH
Recall Posting Date: 2009-05-25
Trade Name: Roche/Hitachi Acetaminophen Assay
Recall Start Date: 2009-05-01
Recall Number: 48042
Hazard Classification: Type III
Model or Catalog #: 3255379190
Lot or Serial #: All Lot Numbers
Reason for Recall: The claim for significant bilirubin interference decreases from 28 mg/dl (478.8 µmol/l) to 20 mg/dl (342 µmol/l) icterus index for the Roche/Hitachi acetaminophen assay.

Top of Page

Manufacturer: Roche Diagnostics GMBH
Recall Posting Date: 2009-06-08
Trade Name: Folate III Reagent Kit
Recall Start Date: 2009-05-08
Recall Number: 48241
Hazard Classification: Type III
Model or Catalog #: 4476433190
Lot or Serial #: 15068201, 15127201
Reason for Recall: Certain lots of the Folate III Reagent Kit may induce an elevated recovery of folate in li-heparin plasma.

Top of Page

Manufacturer: Roche Diagnostics GMBH
Recall Posting Date: 2009-06-08
Trade Name: A) Precicontrol Cardiac
B) Precicontrol Cardiac II
Recall Start Date: 2009-03-26
Recall Number: 47413
Hazard Classification: Type III
Model or Catalog #: A) 03530477190
B) 04917049190
Lot or Serial #: A) N/A
B) N/A
Reason for Recall: Potential for precision issue with the Elecsys Cardiac and Cardiac II. Specifications for the intra-assay precision was not met independent of the Elecsys Digoxin Reagent or Precicontrol lot used.

Top of Page

Manufacturer: Roche Diagnostics GMBH
Recall Posting Date: 2009-06-08
Trade Name: Preciset TDM I / Preciset TDM II
Recall Start Date: 2009-05-12
Recall Number: 48228
Hazard Classification: Type III
Model or Catalog #: 03375781190, 03375790190
Lot or Serial #: 15617400 & 15612200, 15612300
Reason for Recall: Bottle caps are being too difficult to remove.

Top of Page

Manufacturer: Roche Diagnostics Ltd
Recall Posting Date: 2009-05-25
Trade Name: PSM with Validation Module
Recall Start Date: 2009-04-30
Recall Number: 47890
Hazard Classification: Type II
Model or Catalog #: 03009696001, 03265439001
Lot or Serial #: >10 Numbers, Contact Manufacturer
Reason for Recall: Potential situation where the test validation ranges configured in the process systems managers (PSM) can incorrectly release a patient result where there are multiple reference ranges defined.

Top of Page

Manufacturer: Roche Molecular Systems, Inc
Recall Posting Date: 2009-04-27
Trade Name: Factor II (Prothrombin) G20210A Kit
Recall Start Date: 2009-04-06
Recall Number: 47434
Hazard Classification: Type III
Model or Catalog #: 3610195001
Lot or Serial #: All Lots
Reason for Recall: The macro component intended to be used with the Factor II G20210A Kit for LightCycler 2.0 instrument may erroneously identify the C20209T mutation as a wild-type genotype instead of an unknown genotype.

Top of Page

Manufacturer: Sandhill Scientific Inc.
Recall Posting Date: 2009-05-25
Trade Name: Insight Rev H Software-GI Motility System
Recall Start Date: 2009-02-23
Recall Number: 47672
Hazard Classification: Type III
Model or Catalog #: S98-1925-2H
Lot or Serial #: All Lots
Reason for Recall: In HRIM or EFT, patients with non-transmitted esophageal contractions that have been acquired with this software, the report may incorrectly report the esophageal contraction results.

Top of Page

Manufacturer: Siemens AG
Recall Posting Date: 2009-04-27
Trade Name: Update Recall # 35431 previously posted on 2007-06-11.
A) Magic Store System
B) Sienet Magicstore
Recall Start Date: 2007-05-24
Recall Number: 35431
Hazard Classification: Type III
Model or Catalog #: A) 10 014 142, 10 014 154, 10 014 155
B) 8462645
Lot or Serial #: A) 3901384286
B) 3904116228, 3904115986
Reason for Recall: Hardware component is near end of expected life cycle and the RAID Controller can cause a system crash resulting in a loss of data.

Top of Page

Manufacturer: Siemens AG
Recall Posting Date: 2009-05-11
Trade Name: A) Somatom Definition
B) Somatom Definition AS
Recall Start Date: 2009-04-14
Recall Number: 47910
Hazard Classification: Type III
Model or Catalog #: A) 77 40 769
B) 8098027
Lot or Serial #: A) 60148, 60199, 60206, 60235, 60332, 60348, 60422
B) 64032, 64049, 64052, 64069, 64137, 64141, 64233, 64238, 64306, 64316
Reason for Recall: Update the software on bugfixes (i-triggered sequence, bolus monitoring, 3D recon, reconstruction of raw data, 3D intervention, patient delete, AW hangup), kernel changes, graphic driver, and Microsoft hotfix.

Top of Page

Manufacturer: Siemens AG
Recall Posting Date: 2009-05-25
Trade Name: Syngo Imaging Update Package VB30A_HF26
Recall Start Date: 2009-03-04
Recall Number: 47067
Hazard Classification: Type III
Model or Catalog #: 10 014 063
Lot or Serial #: 1094, 01200
Reason for Recall: Due to several root causes leading to missing or mislinked Performed Procedure Step's some or all studies of a patient may become inaccessible from Syngo studio. With a 3rd party RIS, sometimes "study merge" does not work.

Top of Page

Manufacturer: Siemens AG
Recall Posting Date: 2009-06-08
Trade Name: Definition AS
Recall Start Date: 2009-02-25
Recall Number: 48470
Hazard Classification: Type III
Model or Catalog #: 8098027
Lot or Serial #: 64238, 64032, 64049, 64052, 64069, 64137, 64141, 64233, 64306,
64316, 64362
Reason for Recall: This update instruction provides improved fixation of the telescope support.

Top of Page

Manufacturer: Siemens AG
Recall Posting Date: 2009-06-22
Trade Name: Sireskop SX/SD
Recall Start Date: 2009-02-11
Recall Number: 47071
Hazard Classification: Type III
Model or Catalog #: 10093754, 31 11 676, 3111668
Lot or Serial #: 21005, 21040, 21087, 21107, 21110, 31036, 34170, 36103, 41021
Reason for Recall: A defective behaviour in data transport layer of the network file system (NFS) connection could cause series as marked successfully archived even though the content is saved sporadically with defective pixel or header data.

Top of Page

Manufacturer: Siemens Healthcare Diagnostics Inc.
Recall Posting Date: 2009-06-08
Trade Name: Advia 70 Testpoint Haemotology High Con
Recall Start Date: 2009-05-12
Recall Number: 48471
Hazard Classification: Type III
Model or Catalog #: B03-4585-54
Lot or Serial #: TP93037
Reason for Recall: Complaints that the Percent Eosinophils (EOS) is not recovering within the range specified for lot TP93037 of testpoint high control. The supplier confirmed a value assignment error for this lot.

Top of Page

Manufacturer: Siemens Healthcare Diagnostics Inc.
Recall Posting Date: 2009-06-22
Trade Name: Chemiluminescent Substrate
Recall Start Date: 2009-05-06
Recall Number: 48608
Hazard Classification: Type III
Model or Catalog #: L2SUBX
Lot or Serial #: 253, 254
Reason for Recall: Complaints received regarding substrate l2subx lots 253 and 254, which may affect the performance of the Immulite 2000 and Immulite 2500 assays. These substrate lots may introduce a shift in both quality control and patient results.

Top of Page

Manufacturer: Siemens Medical Solutions USA, Inc.
Recall Posting Date: 2009-04-27
Trade Name: A) Syngo Dynamics SD 6.0 Server Software
B) Syngo Dynamics SD 6.0 Workstation Software
Recall Start Date: 2009-02-03
Recall Number: 46562
Hazard Classification: Type III
Model or Catalog #: A) 100 90 370, 100 90 480
B) 100 90 257
Lot or Serial #: A) 95243, 92241, 95248, 93901
B) 93477
Reason for Recall: There is potential issue in the syngo Dynamics 6.0 reporting system. Under certain circumstances, when editing text in a report, it may result in additional phrases not populating as expected.

Top of Page

Manufacturer: Siemens Medical Solutions USA, Inc.
Recall Posting Date: 2009-05-11
Trade Name: Acuson X300 PE Swiftlink
Recall Start Date: 2009-04-07
Recall Number: 47911
Hazard Classification: Type III
Model or Catalog #: 10348531
Lot or Serial #: 313288, 313171, 313273
Reason for Recall: Swiftlink adapters manufactured prior to October 2008 can cause a failure that results in image quality when using Acunav catheter transducers that does not support intra-cardiac diagnosis or procedure guidance.

Top of Page

Manufacturer: Siemens Medical Solutions USA, Inc.
Recall Posting Date: 2009-05-11
Trade Name: Acuson S2000
Recall Start Date: 2009-04-14
Recall Number: 48076
Hazard Classification: Type III
Model or Catalog #: 10041461
Lot or Serial #: 200252, 200926, 200979, 200995
Reason for Recall: When performing a tee exam with the V5MS Transducer, CW (continuous wave) mode is not functional. A waveform signal cannot be detected. This event occurs on every attempt to acquire a CW signal.

Top of Page

Manufacturer: Siemens Medical Solutions USA, Inc.
Recall Posting Date: 2009-05-25
Trade Name: Acuson S2000 VA10
Recall Start Date: 2009-04-14
Recall Number: 48077
Hazard Classification: Type II
Model or Catalog #: 10041461
Lot or Serial #: 200334, 200288
Reason for Recall: A series of events could cause the last image to be stored with the next new patient performed, L Teslia Mass 2 measurement label appears in the report in English only, more than 4 measurements may print.

Top of Page

Manufacturer: Siemens Medical Solutions USA, Inc.
Recall Posting Date: 2009-05-25
Trade Name: A) Acuson Sequoia 512 Ultrasound System
B) Acuson Sequoia C512 Echocardiography System
C) Acuson Sequoia C512 Echocardiography System
D) Acuson Sequoia 512 Ultrasound
Recall Start Date: 2009-04-02
Recall Number: 47909
Hazard Classification: Type III
Model or Catalog #: A) 82 45 875
B) 8255412, 8267697
C) 10038242
D) 10038241
Lot or Serial #: A) 53736, 54558, 55331, 61377, 63210
B) 53418, 57395
C) 68153, 68211, 68217, 68328, 68330, 68335, 68365, 68366, 68368, 69281, 69291
D) 68444, 65685
Reason for Recall: To inform our customers of a potential software problem with the Acuson Sequoia Ultrasound System that may result in overheating of the auxiliary 2 mHz continuous wave (CW) transducer.

Top of Page

Manufacturer: Siemens Medical Solutions USA, Inc.
Recall Posting Date: 2009-05-25
Trade Name: Kinedx 4.2 SPF Reporting Workstation
Recall Start Date: 2009-02-05
Recall Number: 46559
Hazard Classification: Type III
Model or Catalog #: N/A
Lot or Serial #: 92172-1
Reason for Recall: Under certain circumstances, when editing text in a report, it may result in additional phrases not populating as expected.

Top of Page

Manufacturer: Siemens Medical Solutions USA, Inc.
Recall Posting Date: 2009-05-25
Trade Name: Syngo Dynamics Server Software
Recall Start Date: 2009-03-04
Recall Number: 47064
Hazard Classification: Type III
Model or Catalog #: 100 90 480
Lot or Serial #: >10 Numbers, Contact Manufacturer
Reason for Recall: There is potential issue in the Syngo Dynamics 5.1 reporting system. Under certain circumstances, when editing text in a report, it may result in additional phrases not populating as expected.

Top of Page

Manufacturer: Siemens Medical Solutions USA, Inc.
Molecular Imaging Group
Recall Posting Date: 2009-05-25
Trade Name: A) Symbia T/T2/T6/T16
B) Symbia S
Recall Start Date: 2009-03-04
Recall Number: 47070
Hazard Classification: Type III
Model or Catalog #: A) 08717733, 10275007, 10275008, 10275009, 10275010
B) 08717741
Lot or Serial #: A) 1103, 1128, 1150, 1153, 1193, 1199, 1018, 1026, 1058, 1056, 1024, 1012
B) 1143, 1112, 1159
Reason for Recall: Possibility a patient injury can occur when the patient is lying on the patient bed and the automatic collimator changer is undergoing a collimator change operation even when the patient bed is retracted.

Top of Page

Manufacturer: Siemens Medical Solutions USA, Inc.
Oncology Care Systems
Recall Posting Date: 2009-05-25
Trade Name: A) Artiste Syngo RT Therapist Assist
B) Artiste Syngo RT Therapist
Recall Start Date: 2009-04-21
Recall Number: 48254
Hazard Classification: Type III
Model or Catalog #: A) 08162807
B) 08162815
Lot or Serial #: A) 10024
B) 10040
Reason for Recall: When all plans are loaded on the device, if the beam plan is edited, accessory information in the lantis can be potentially overwritten or removed, could result in mistreatment on another linear accelerator.

Top of Page

Manufacturer: Smith & Nephew, Inc., Endoscopy Division
Recall Posting Date: 2009-06-22
Trade Name: Disposable Endoscopic Surgery Blades
Recall Start Date: 2009-05-08
Recall Number: 48408
Hazard Classification: Type II
Model or Catalog #: 7206010, 7206011, 7210499
Lot or Serial #: 20148707, 20148714, 20153849, 20153865, 20154971
Reason for Recall: There is the potential for a compromised sterile barrier in the tyvek lid of the primary packaging.

Top of Page

Manufacturer: Smith & Nephew, Inc., Endoscopy Division
Recall Posting Date: 2009-06-22
Trade Name: Dyonics 25 Tube Set Kits
Recall Start Date: 2009-05-29
Recall Number: 48968
Hazard Classification: Type II
Model or Catalog #: 7211005, 7211006
Lot or Serial #: > 10 Numbers, Contact Manufactuer
Reason for Recall: The material thickness of the trays used for packaging the tube sets may not be sufficient to maintain the sterile barrier.

Top of Page

Manufacturer: Smiths Medical MD Inc.
Recall Posting Date: 2009-05-25
Trade Name: CADD-SOLIS Rechargeable Battery Pack
Recall Start Date: 2009-04-30
Recall Number: 48233
Hazard Classification: Type III
Model or Catalog #: 21-2160-51
Lot or Serial #: >10 Numbers, Contact Manufacturer
Reason for Recall: Reports received that when the battery pack is first installed in pump, the pump will not power up or an alarm sounds and an error message displays indicating that battery pack is unusable and pump will not run.

Top of Page

Manufacturer: Sonomed Inc.
Recall Posting Date: 2009-05-11
Trade Name: Vumax Ophthalmic Ultrasound Scanner
Recall Start Date: 2009-04-13
Recall Number: 47987
Hazard Classification: Type II
Model or Catalog #: SHFS35-S
Lot or Serial #: 3550-0207-0178, 3550-0108-0244, 3550-0207-0177, 3550-0408-0258, 3550-0707-0213, 3550-0707-0215, 3550-0708-0271, 3550-0907-0220, 3550-0908-0277, 3550-0908-0278, 3550-0108-0252, 3550-0207-0179, 3550-1106-0147, 3550-1106-0148
Reason for Recall: The Vumax Ophthalmic Ultrasound System may, under certain circumstances, return measurement values on the order of 1/2 or 2x the actual value. Root cause is a software conflict within software version V2.0.06E.

Top of Page

Manufacturer: Spacelabs Medical, Inc.
Recall Posting Date: 2009-04-13
Trade Name: Medical Flat Panel Power Supply
Recall Start Date: 2009-03-25
Recall Number: 47582
Hazard Classification: Type II
Model or Catalog #: 010-1619-00, 010-1655-00
Lot or Serial #: 0647, 0703, 0706, 0707, 0709, 0712, 0724, 0727, 0728, 0732
Reason for Recall: The external power supply used with certain models of the Spacelabs Medical 19" flat panel displays may fail prematurely, causing the display to go blank. Audio alarms continue to function normally.

Top of Page

Manufacturer: Steris Corporation
Recall Posting Date: 2009-06-22
Trade Name: Steris CMAX Surgical Table Hand Control
Recall Start Date: 2009-05-22
Recall Number: 48912
Hazard Classification: Type III
Model or Catalog #: N/A
Lot or Serial #: AC001 TO AC0221
Reason for Recall: A limited quantity of the CMAX Hand Controls were manufactured without loctite thread locker on the screws that attach the mounting clip to the hand control case. It is possible that screws without the loctite can work loose and the clip can become separated from the hand control. If both screws back out completely, the internal components of the hand control and/or the table control board may become damaged. This could cause a loss of hand functionality.

Top of Page

Manufacturer: Stryker Communications
Recall Posting Date: 2009-06-08
Trade Name: Vertier Table Headrest Attachment
Recall Start Date: 2009-05-15
Recall Number: 48498
Hazard Classification: Type II
Model or Catalog #: 0788-300-012
Lot or Serial #: All Lot Numbers
Reason for Recall: The headrest has two pinch points that could result in hospital staff injury during the transportation of the headrest when it is detached from the table.

Top of Page

Manufacturer: Stryker Endoscopy
Recall Posting Date: 2009-05-25
Trade Name: Pneumo Sure XL High Flow Insufflator
Recall Start Date: 2009-01-08
Recall Number: 45983
Hazard Classification: Type II
Model or Catalog #: 620-040-600, 620-040-610
Lot or Serial #: 0804CE394 to 0810CE295
Reason for Recall: Insufflators are powering off during surgery or not powering up completely.

Top of Page

Manufacturer: Stryker Medical
Recall Posting Date: 2009-04-13
Trade Name: 1550 Electric Stetcher With Quick Drop
Recall Start Date: 2009-03-16
Recall Number: 47353
Hazard Classification: Type II
Model or Catalog #: 1550-000-000
Lot or Serial #: > 100 Numbers, Contact Manufacturer
Reason for Recall: Stretcher fowlers (backrests) may develop a grinding noise from wear of drive nut threads in the fowler. If the stretcher continues to be used, the fowler may inadvertently drop to its lowest (flat) position.

Top of Page

Manufacturer: Stryker Spine SAS
Recall Posting Date: 2009-06-08
Trade Name: A) MANTIS Rod Inserter
B) MANTIS Rod Inserter Inner Shaft
Recall Start Date: 2009-04-28
Recall Number: 48210
Hazard Classification: Type II
Model or Catalog #: A) 48284050
B) 48284051
Lot or Serial #: A) All Lot Numbers
B) All Lot Numbers
Reason for Recall: The stainless steel split sphere in the Mantis Rod Inserter Shaft has the potential to become deformed when subjected to high force. Once deformed, the split sphere may separate from the shaft.

Top of Page

Manufacturer: Sunrise Mobility Products Division
Recall Posting Date: 2009-05-11
Trade Name: Quickie LXI Manual Wheelchair
Recall Start Date: 2009-02-02
Recall Number: 47380
Hazard Classification: Type II
Model or Catalog #: LXI
Lot or Serial #: LXI-034741, LXI-034609, LXI-034740, LXI-034500
Reason for Recall: Stabilizer bar was inadvertently omitted from the configuration due to a system error. Stabilizer bar adds rigidity to the back to reduce head movement should the chair be involved in a vehicular collision.

Top of Page

Manufacturer: Synthes (Canada) Ltd.
Recall Posting Date: 2009-05-11
Trade Name: In-Situ Bender/Cutter
Recall Start Date: 2009-04-09
Recall Number: 47833
Hazard Classification: Type II
Model or Catalog #: 530.521S, 530.522S
Lot or Serial #: All Lots
Reason for Recall: During examination of shelf life samples as part of real time shelf life validation, the company became aware of and confirmed a breach of the sterile pouch barrier.

Top of Page

Manufacturer: Technidata S.A.S.
Recall Posting Date: 2009-04-27
Trade Name: TD-Synergy Software On TD-Microbiology
Recall Start Date: 2009-04-02
Recall Number: 47834
Hazard Classification: Type I
Model or Catalog #: TD-SYN-01
Lot or Serial #: N/A
Reason for Recall: MIC (Minimum Inhibitory Concentration) result interpretation can be corrupted and an antibiogram could be reported as sensitive instead of resistant or vice versa.

Top of Page

Manufacturer: Teleflex Medical
Recall Posting Date: 2009-04-13
Trade Name: Coronary Scissors 7"
Recall Start Date: 2009-03-09
Recall Number: 47208
Hazard Classification: Type II
Model or Catalog #: 352164, 352165, 352166, 352167, 352168
Lot or Serial #: Date Codes RR8, SS8, TT8, UU8, VV8, WW8, XX8, MM9.
Reason for Recall: Manufacturing defect consisting of a rough square finish to the scissor tips, rather than a smooth rounded point, may cause damage to the inner wall of the blood vessel, rendering it unsuitable for bypass graft.

Top of Page

Manufacturer: Terumo Cardiovascular Systems Corp.
Recall Posting Date: 2009-06-08
Trade Name: Terumo Advanced Perfusion System 1
Recall Start Date: 2009-01-12
Recall Number: 46050
Hazard Classification: Type II
Model or Catalog #: 801763
Lot or Serial #: 0013, 0017, 0020, 0021, 0144, 0193, 0396, 0601
Reason for Recall: Screws in the power manager board may come loose and come into contact with system 1 chassis.

Top of Page

Manufacturer: Terumo Cardiovascular Systems Corp.
Recall Posting Date: 2009-06-08
Trade Name: Advance Perfusion System 1
Recall Start Date: 2009-01-29
Recall Number: 46444
Hazard Classification: Type II
Model or Catalog #: 802100
Lot or Serial #: 31, 39, 55, 93, 219, 220, 263, 279, 584
Reason for Recall: Poor or intermittent connections. A non functioning CCM could potentially cause the user to operate pumps using local pump controls.

Top of Page

Manufacturer: Trainer's Choice
Recall Posting Date: 2009-06-22
Trade Name: Hinged Knee Brace
Recall Start Date: 2009-01-07
Recall Number: 48389
Hazard Classification: Type III
Model or Catalog #: 101
Lot or Serial #: 8-31313-00003-2, 8-31313-00004-9, 8-31313-00002-5
Reason for Recall: Evidence of mold was found on the leather pieces on the outside of the braces. Product integrity and effectiveness was not affected.

Top of Page

Manufacturer: Uniprix Inc.
Recall Posting Date: 2009-04-13
Trade Name: A) Option + Sterile PADS 5cm X 5cm
B) Option + Steriles PADS 10cmX10cm
Recall Start Date: 2009-03-13
Recall Number: 47475
Hazard Classification: Type III
Model or Catalog #: A) 771290064484
B) 771290064491
Lot or Serial #: A) 10380, 10381
B) 10381
Reason for Recall: Some sterile pads that had not been sterilized were released for sale.

Top of Page

Manufacturer: Unomedical A/S
Recall Posting Date: 2009-04-13
Trade Name: Paradigm Silhouette Infusion Sets
Recall Start Date: 2009-04-01
Recall Number: 47734
Hazard Classification: Type II
Model or Catalog #: MMT-377600, MMT-378600, MMT-381600, MMT-382600
Lot or Serial #: 617095, 616520, 616521, 617090, 617094, 616522, 617089, 617093, 616523
Reason for Recall: A typographical error in the fixed prime volume listed in instructions for use. IFU tells users to fill empty space in the cannula with a fixed prime volume of 0.3 units of U-100 insulin, instead of 0.7 units.

Top of Page

Manufacturer: Varian Medical Systems, Inc.
Recall Posting Date: 2009-06-22
Trade Name: Aria Radiation Oncology
Recall Start Date: 2009-05-08
Recall Number: 49074
Hazard Classification: Type II
Model or Catalog #: 8.1.15, 8.5.11, 8.6.07, HIT
Lot or Serial #: > 10 Numbers, Contact Manufactuer
Reason for Recall: Software anomaly leads to a record save fail in the case that a partially treated fraction has zero dose accumulation. If the change to the plan had been to parameters other than dose per fraction, treatment to incorrect volume could result, potentially leading to serious injury.

Top of Page

Manufacturer: Viewsonic Corporation
Recall Posting Date: 2009-05-25
Trade Name: VGM 19" Monitor
Recall Start Date: 2009-04-21
Recall Number: 48079
Hazard Classification: Type II
Model or Catalog #: VG930M
Lot or Serial #: S/NS > QC2082880001
Reason for Recall: 48 complaints reporting that the monitors lost power unexpectedly or when they attempted to power up which resulted in loss of both visual and secondary alarm enunciation from the LCD flat panel.

Top of Page

Manufacturer: Wallac OY
Recall Posting Date: 2009-04-27
Trade Name: Delfia Xpress PAPP-A
Recall Start Date: 2009-03-26
Recall Number: 47713
Hazard Classification: Type III
Model or Catalog #: 6003-0020
Lot or Serial #: 510998, 515079, 511590
Reason for Recall: Some tracer bottles in the Delfia Xpress PAPP-A kit have bar codes which cannot be read in the Delfia Xpress instrument.

Top of Page

Manufacturer: Wallac OY
Recall Posting Date: 2009-04-27
Trade Name: Neogram Amino Acids Mass Spec Kit
Recall Start Date: 2009-04-01
Recall Number: 47714
Hazard Classification: Type II
Model or Catalog #: 3026-0010, 3026-0030
Lot or Serial #: Contact Manufacturer
Reason for Recall: The truncated V-Bottomed Microplates delivered as a package of 10 plates may have occasional contamination which results in an apparent elevated C4 concentration in an affected well.

Top of Page

Manufacturer: Walter Lorenz Surgical, Inc. Also Trading As: Biomet Microfixation
Recall Posting Date: 2009-04-13
Trade Name: Byrd Screw 2.0x6mm Self Drilling
Recall Start Date: 2009-02-20
Recall Number: 46721
Hazard Classification: Type II
Model or Catalog #: 01-0267
Lot or Serial #: 91807107
Reason for Recall: The 01-0267 Byrd screw may break when being used.

Top of Page

Manufacturer: Walter Lorenz Surgical, Inc. Also Trading As: Biomet Microfixation
Recall Posting Date: 2009-05-25
Trade Name: 09-0142, Dean Scissors
Recall Start Date: 2009-04-02
Recall Number: 47701
Hazard Classification: Type II
Model or Catalog #: 09-0142
Lot or Serial #: >10 Numbers, Contact Manufacturer
Reason for Recall: The 09-0142, Dean Scissors are breaking when used.

Top of Page

Manufacturer: Zimmer Inc.
Recall Posting Date: 2009-05-25
Trade Name: A) Nexgen LPS
B) Nexgen LPS-Flex Femoral Components
Recall Start Date: 2009-04-23
Recall Number: 48206
Hazard Classification: Type II
Model or Catalog #: A) 00-5964-014-51, 00-5964-017-51
B) 00599601451
Lot or Serial #: A) 61219714, 61204820
B) 61207901
Reason for Recall: These items may possess a nonconforming finish on the polished surfaces which could potentially increase wear and decrease the product life cycle on the articulated surface.

Top of Page

Manufacturer: Zimmer Inc.
Recall Posting Date: 2009-06-08
Trade Name: TransFx Drill Bit
Recall Start Date: 2009-05-06
Recall Number: 48337
Hazard Classification: Type II
Model or Catalog #: 00-4450-054-00, 00-4450-056-00,
00-4450-058-00, 00-4450-063-00
Lot or Serial #: 56454683, 70196100, 70185600, 70221300, 56454692, 70193000,
70205400
Reason for Recall: Device possesses non-conforming tip geometry, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.

Top of Page

Manufacturer: Zimmer Inc.
Recall Posting Date: 2009-06-22
Trade Name: ZMR Hip System-Stems
Recall Start Date: 2009-05-27
Recall Number: 48913
Hazard Classification: Type II
Model or Catalog #: 00-9982-015-18
Lot or Serial #: 60698102
Reason for Recall: The stem threads on some units in this lot may be nonconforming, preventing the compression nut from engaging on the stem.

Top of Page

Manufacturer: Zimmer Inc.
Recall Posting Date: 2009-06-22
Trade Name: 2.7mm Cortical Screw Self-Tapping
Recall Start Date: 2009-06-01
Recall Number: 48914
Hazard Classification: Type II
Model or Catalog #: 00-4827-024-01
Lot or Serial #: 60886890
Reason for Recall: The 2.7mm Cortical Screw Self-Tapping package could potentially hold the 4.0mm cancellous screw partially threaded (part number 00-4840-022-01).

Top of Page

Manufacturer: Zimmer Inc.
Recall Posting Date: 2009-06-22
Trade Name: Alumina Ceramic Femoral Head
Recall Start Date: 2009-06-01
Recall Number: 48988
Hazard Classification: Type II
Model or Catalog #: 00-6428-032-02
Lot or Serial #: 61007046
Reason for Recall: Some units in this lot may have the inner tyvek peel tab trapped within the outer seal. This configuration could result in delamination of the inner tyvek seal as the package is opened, complicating removal of the implant from the package while maintaining sterility.

Top of Page

Manufacturer: Zimmer Trabecular Metal Technology, Inc.
Recall Posting Date: 2009-06-08
Trade Name: TM-400 Broach Handle
Recall Start Date: 2009-05-08
Recall Number: 48453
Hazard Classification: Type II
Model or Catalog #: 96-210-10001
Lot or Serial #: All Lots
Reason for Recall: Device may fracture at the threaded tip during use, leaving the broach or trial in the surgical site.

Trade Name

Manufacturer

Recall Posting Date

Drug and Medical Device Recall Listings

Common menu bar links

Institutional links

Current Subject

Explore...

Proactive Disclosure

Medical Device Recall Listings - Sorted by Manufacturer

(From April 2009 - June 2009)