Notices in alphabetical order
by manufacturer
(2006 - 2010)

A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z

Note: To find recall articles from the past 12 months, log in to Supply Chain Advisor. Click on the News-Resources tab (Select "recalls" under content type and then search by specific product, contract category and/or date range). Consult the FDA Web site and/or the manufacturer for additional information. Listing of notices in chronological order of date issued.

A

Abbott

• Abbott Glucose Test Strips 02/15/11
• Abbott Vascular issues voluntary device recall on POWERSAILA® Coronary Dilation Catheters (8/12/09)

Alcon Research LTD

• Alcon Research LTD doing business as Alcon Laboratories, Inc. - CONSTELLATION Vision System (07/20/2010)

Alliant Healthcare

• Alliant Healthcare Products issues recall on TruChoice products 8/8/2011

AngioScore Inc.

Ansel Healthcare

• Ansell Healthcare Issues a voluntary recall on the Encore Underglove 6/19/2011
• Ansell Healthcare issues a voluntary recall on Derma Prene Ultra Surgical Gloves (5/23/09)

Apogee Medical

• Apogee Medical issues voluntary recall on intermittent catheters (7/31/2008)

Arrow

Arstasis

Arizant

• Arizant recalls Ranger standard flow blood/fluid warming disposable sets (7/01/07)

Ascent

• Ascent announces voluntary recall of AutoSuture trocar model V2 (11/07/06)

Atrium Medical Corporation

• Atrium issues voluntary recall on Hydraglide™ heparin- coated thoracic drainage catheters. (05/29/2008)
• W.L. Gore and Atrium surgical mesh products safe and effective (3/26/07)
• Atrium Medical Corporation recalls chest drain/express BRU with sterile fluid path assembly (11/8/06)

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B

Bard

• Bard Access Systems, Inc. issues recall on HuberPlus™ Non-Coring Needle Safety Infusion Sets (2/17/2010)
• Bard Electrophysiology issues recall on Bard Channel FX Transseptal Sheath Kit (2/17/2010)
• Bard Electrophysiology discontinues original woven catheter end items, introduces new SURELINK© cable connector with replacement product (5/6/09)
• Bard issues voluntary recall on Recovery Cone Removal System. (05/29/2008)
• Bard Composix Kugel Patch expanded recall and market withdrawal (1/30/07)
• Bard Peripheral Vascular (BPV) recalls G2: filter system (12/27/06)
• Update: Bard Composix Kugel Patch Recall (PP-OR-188) (3/31/06)
• Bard Composix Kugel Patch Recall: Contract PP-OR-188 (01/05/06)

Baxa

• Baxa Corporation issues recall on ExactaMix TPN Bags (12/03/09)

Baxter

• Baxter Healthcare Corporation issues recall on Y-Type Blood Solution Sets, Product Code 2C8750 (1/14/10)
• Baxter issues voluntary urgent product recall on AS50 Infusion Pump (9/25)
• Baxter issues urgent product recall on Intralipid IV Fat Emulsions (3/21/08)
• Baxter Healthcare recalls Heparin lots due to increased adverse patient reactions (01/25/08)
• Baxter expands recall of pumps over falsified data (8/13/07)
• FDA classifies Baxter's field corrective action as a Class I recall for triple channel pumps (7/26/07)
• Baxter Healthcare recalls Vented Paclitaxel Administration sets (3/1/07)

Beckton Dickinson (BD)

• BD issues recall on 60 ml Luer-Lok™ Syringes (7/31/2008)
• BD reports its products were not part of recent heparin syringes recalls (4/17/08)
• BD recalls Vacutainer Luer-Lok Access Device (PP-LA-148) (9/7/06)
• BD recalls selected lots of Push Button Blood Collection Set with Pre-Attached Holder (PP-LA-147) (8/21/06)
• BD issues urgent voluntary recall on one ml SafetyGlide syringes (8/09/06)
• BD recalls Safety Phlebotomy (PP-LA-147) and Blood Specimen Collection (PP-LA-148) products (7/7/06)

Beckman Coulter

• Beckman Coulter issues Class I Recall on Synchron® LX® 20, LX 20 PRO, LXi 725 Clinical Systems 5/27/11

Becton, Dickson and Company

• Becton, Dickinson and Company issues recall on Nexiva™ Closed IV Catheter System (2/17/2010)

Boston Scientific

• Non-Sterile Boston Scientific Devices Stolen Endoscopy and Urology / Women's Health Devices 5/3/11
• Boston Scientific recalls AccuStick II introducer systems as the radiopaque marker may fall off (9/12/07)
• Boston Scientific impulse angiographic catheters may be mislabeled (7/10/07)
• Boston Scientific/Guidant recalls implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators (4/16/07), updated 5/9/07
• Boston Scientific recalls Wallstent biliary endoprostheses (7/27/06)
• Guidant (now part of Boston Scientific Corporation) issues recall on various cardiac pacemakers and defibrillators (6/23/06)

B. Braun Medical

• B. Braun issues a recall on specific lots of IV Sets (4/8/09)
• Braun issues voluntary recall on burette sets (7/2/2008)
• B. Braun Medical Inc was notified by its contract manufacturer, AM2PAT Inc (Raleigh, NC), of a nationwide recall of all lots and sizes of Pre-filled Heparin and Saline Flush Syringes. (01/25/08)

Biomerieux

• BioMerieux, Inc., VITEK 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam (TZP) 11/10/10

 

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C

CareFusion

• CareFusion issues notice on iodine based products (12/03/09)
• CareFusion Corporation issues recall/notice update on recall of the Alaris system (9/02/09)

Cardinal

• Cardinal Health issues a recall for Medi-Vac Non-Conductive Tubing (9/8/2010)
• Cardinal Health issues urgent safety alert regarding therapy feature used with Alaris PCA module (model 8120) (5/6/09)
• Cardinal Health to discontinue latex gloves (5/6/09)
• Cardinal updates recall notification for Alaris pumps model 8100 (1/30/08)
• Cardinal Alaris recalls its Alaris® pump model 8100, as a result of inaccurate flow rate related to misassembled (missing, bent or broken) springs during manufacturing or servicing in the mechanism assembly.  (01/10/2008)
• Cardinal SE Gold IV Pump Recall - Technical Solution and Follow up (12/10/06)
• Cardinal issues urgent voluntary recall on Alaris SE (formerly Signature Edition) IV pumps (8/22/06)

Cepheid

• Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System (07/02/2010)

Cobe Cardiovascular

• Cobe Cardiovascular recalls Dideco Electa Essential and Compact Advanced autotransfusion wash sets (8/15/06)

ConMed

• ConMed issues recall on ConMed GoldLine rocker switch pencils, contained in Avid custom procedure trays (4/30/10)
• ConMed issues urgent medical device recall regarding Linvatec Lightwave Ablator IA-2000-s (8/6/09)
• ConMed issues urgent medical device recall regarding Linvatec ARTHRO-KNIFE (8/6/09)
• ConMed issues urgent medical device recall regarding Linvactec Ultrapower Diamond Wheel Burs (8/6/09)
• ConMed issues recall of R2 Adult Multifunction Electrodes (11/20/2008)
• ConMed recalls laparoscopic instrument manufactured between October 2003 and February 2005 (PP-OR-165) (4/14/06)

Cook

• Cook Medical - Ciaglia Blue Rhino and Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays that Contain a Covidien 6PERC or 8PERC Shiley Tracheostomy Tube (8/4/2010)
• Cook issues alert on wire guides lacking manufacturer's name and address (9/05/07)

Country Pure Foods, Inc.

• Country Pure Foods, Inc. (Juice4u) substitutes Vita-Gold brand orange juice for Thirster brand orange juice (3/13/07)

Covidien

• United States Surgical (Covidien) Issues a Voluntary Recall of specific lots of the LigaSurea Dolphin Tip Sealer/Divider 11/28/11
• Covidien issues voluntary recall on all unexpired lots of MD-Gastroview contrast media in 120 mL and 240 mL bottles 7/13/2011
• Covidien issues a voluntary recall of cuffed Shiley™ tracheostomy products (4/30/10)
• United States Surgical (Covidien) issues a voluntary recall of the ProTack™ fixation device (2/17/2010)
• Covidien issues update on global molybdenum 99 (Mo99) supply situation (9/02/09)
• Update: Covidien's alert on the Shiley 3.0 PED cuffless pediatric tracheostomy tube has been upgraded to a voluntary recall (5/6/09)
• Covidien's Kangaroo ePump™ and Kangaroo Joey™ enteral feeding sets may experience priming problems (5/6/09)
• Covidien recalls Monoject Prefilled Heparin syringes (4/17/08)

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D

Davol Inc.

• Davol Inc. issues voluntary recall on XenMatrix Surgical Graft 2/16/2011

Draeger Medical, Inc.

• Draeger Medical issues recall on Oxylog 3000 ventilator (11/06/08)
• Urgent product recall: Draeger Babylog 8000plus Neonatal Ventilators (6/6/06)

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E

Edwards Lifesciences Corp.

• Edward Life Sciences issues recall on Fogarty Occlusion Catheter (7/24/09)
• Edwards Lifesciences issues recall on "Swan-Ganz Continuous Cardiac Output (CCO)" Catheters (2/26/2009)
• Edwards Lifesciences recalls pediatric Venous Arterial Blood Management Protection systems (4/3/08)
• Edwards Lifesciences recalls one lot of Swan-Ganz thermodilution VIP catheters (12/19/06)
• Edwards Lifesciences Corporation issues voluntary recall of Vigilance monitors with software release 5.3 or earlier (6/30/06)

Ethicon

• Ethicon Endo issues a voluntary recall of the ENDOPATH® ETS Compact Flex 45mm Articulating Linear Cutters 8/24/2011
• Ethicon issues voluntary recall on Dermabond Topical Skin Adhesive products 2/16/2011
• Ethicon Endo-Surgery expands recall of ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters (5/14/2009)
• Ethicon recalls multiple lots of absorbable sutures (2/18/2009)
• Ethicon issues urgent voluntary product recall on VICRYL RAPIDE Suture (8/28/2008)
• Ethicon initiates voluntary recall of 9 codes of VICRYL RAPIDE (polyglactin 910) Suture (8/17/2008)
• Ethicon initiates voluntary recall of Endopath ETS 35mm cartridges and related products. (05/29/2008)

EV3

 

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F

Fresenius

FDA

• FDA - Class I Recall and Safety Investigation of Counterfeit Polypropylene Surgical Mesh (6/10/2010)

G

Gaymar

• Gaymar Industries issues recall on certain products experiencing design problems with the power cords 2/16/2011

Gore, W. L.

• W.L. Gore and Atrium surgical mesh products safe and effective (3/26/07)

Guidant

• Boston Scientific/Guidant recalls implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators (4/16/07), updated 5/9/07
• Guidant (now part of Boston Scientific Corporation) issues recall on various cardiac pacemakers and defibrillators (6/23/06)
• Update on recall: Guidant pacemakers (1/25/06)

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H

Hettich

• Hettich issues manufacturer’s hold, recall on centrifuge rotors and buckets (7/2/2008)

Hospira

• Hospira Inc. issues recall on specific lots of GemStar pump sets (9/1/2010)
• Hospira Inc. issues recall on AC power cords (9/08/09)

I

Integra NeuroSciences

• Integra Surgical issues a voluntary recall of the Luxtec Ultralite Pro headlight 10/28/11
• Intergra NeuroSciences Issues a Voluntary Recall of the Neuroballoon Catheter (9/22/2010)
• Integra NeuroSciences issues recall on Integra Neuroballon Catheters (Catalog number 7CBD10) (9/2/2010)
• Integra recalls all EnDura No-React Dural Substitute products (5/10/07)

Ikaria Holdings

• Ikaria Holdings, INOMAX DS Drug Delivery System (8/23/2010)

J

Johnson & Johnson

• Johnson & Johnson Healthcare recalls FETALSCREEN™ kits (1/9/07)

K

Kimberly Clark

• Kimberly-Clark Health Care receives an updated 510(k) clearance to market the KC300 KimGuard One-Step (2/17/2010)

L

Lantheus Medical Imaging

• Lantheus Medical Imaging recalls lot 3955 of Cardiolite (7/2/2008)

Leonhard Lang

• Leonhard Lang USA issues urgent medical device recall for Skintact DF20 Defibrillation Electrodes (6/25/09)

Liko

• Liko initiates corrective program on Uno Patient Lift (5/6/09)

Lumenis

• Lumenis Laser Recall (PP-CE-239) (2/1/06)

M

Madela, Inc.

• Medela Inc. issues a recall for certain hospital kit products (9/1/2010)
• Medela product return: Sterile 80ml container and lid (6/16/06)

Mallinckrodt

• Mallinckrodt issues voluntary recall on all unexpired lots of MD-Gastroview contrast media in 120 mL and 240 mL bottles 7/29/2011
• Update: Mallinckrodt Recall of Technetium (Tc99M) Generators (3/10/07)
• Mallinckrodt Technetium Generator Reimbursement Program PP-RA-006 (1/19/06)

Maquet, Inc. (a division of Getinge, Inc.)

• Maquet Cardiovascular issues a voluntary recall on select lots of ACROBAT V, ACROBAT SUV, ACROBAT Mechanical Stabilizers, XPOSE 3 Positioner and XPOSE 4 Positioner 11/17/11
• Maquet issues device correction on PRISMATIC triple surgical lights (5/6/09)

Medivators

• Manufacturer Recalls Disinfecting Equipment After Failure To Properly Sterilize Device (6/25/2010)

Medline Industries

• Medline Industries, Inc. received recall notice from Ventlab Corporation for anesthesia breathing bag (12/13/2007)

Medtronic

• Medtronic USA issues notice on Concerto® and CRT-D and Virtuoso ICD devices (9/24/09)
• Medtronic issues wire separation notice regarding subsets of Kappa® and Sigma® pacemakers (8/12/09)
• Medtronic issues wire separation notice regarding subsets of Kappa® and Sigma® pacemakers (7/24/09)
• Medtronic issues urgent voluntary correction for LIFEPAK 20 defibrillator/monitors (9/7/06)

Merit

Multi-Med

• Multi-Med, Inc., 22 Gauge x 1 inch Straight and Right Angle Huber Needles and Navilyst Medical Inc., Vaxcel Implantable Vascular Access Systems Containing Huber Needles (Two Class I Recalls) (8/26/2010)

 

N

Natus

• Natus has issued a voluntary recall of the Bio-logic cart used in neurology and/or sleep applications (PP-MM-023).  (02-07-08)

O

Olympus America

• Olympus issues reminder to reprocess MAJ-855 Auxiliary Water Tube following endoscopy procedures (5/6/09)
• Olympus issues reminder to reprocess MAJ-855 Auxiliary Water Tube (03/09)

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P

Posey

• Posey issues voluntary recall on Synthetic Leather and Biothane Waist and Wrist Restraints.  (9/11/2008)

Penumbra

Physio-Control Inc.

• Physio-Control Inc., LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors (07/02/2010)

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R

Respironics

• Respironics Novametrix LLC has initiated a voluntary recall 7/29/2011

S

Sage Products, Inc.

• Sage issues voluntary recall on 2% Chlorhexidine Gluconate (CHG) cloth patient preoperative skin products (7/2/2008)
• Sage Products Inc. issues voluntary recall of Comfort Shield Perineal Care washcloths (6/21/06)

Shelhigh

• FDA requests recall of all Shelhigh medical devices (5/09/07)

Sigma

• Sigma issues recall on Spectrum Infusion Pump Model 35700 (9/29/2010)

Smith & Nephew, Inc.

• Smith & Nephew Endoscopy issues voluntary recall of DYONICS 25 tubeset kits (6/25/09)
• Smith & Nephew, Inc. issues recall for suture passer (4/4/07)

Smiths Medical

• Smiths Medical issues voluntary recall on Portex Pediatric Tracheal Tubes (9/24/09)
• Smiths Medical recalls CADD® Medication Cassette Reservoirs from Smiths Medical (01/10/2008)
• Smiths Medical recalls its level 1 normothermic I.V. fluid administration and irrigation sets (8/1/07)
• Smiths Medical recalls CADD administration sets with flow stop free-flow protection (4/16/07)
• Smiths Medical recalls 100 ml CADD medication cassette reservoirs with flow stop free-flow protection (4/16/07)
• Smiths Medical recalls Medfusion 3500 syringe infusion pump with PharmGuard medication safety software (3/1/07)
• Smiths Medical laryngectomy tube mislabeled (12/21/06)
• Smiths Medical recalls continuous epidural tray (11/01/06)
• Blue Line Ultra tracheostomy tube recall (PP-OR-072) (3/17/06)
• Urgent device correction on Smiths Medical MD Inc. IPump, PCA II and AP II devices (01/10/06)

Spacelabs Medical

• SpaceLabs issues various medical device correction notices (8/13/2008)
• Spacelabs Medical advises of potential hazard with Ultraview SL command module, model 91496-M (1/3/07)

STERIS

• FDA extends Steris System I transition time to 18 months (2/2/10)
• U.S Food and Drug Administration issues notification and recommendations on Steris System 1 processor (1/14/10)
• STERIS recalls C1160 tray accessory used with SYSTEM 1 Sterile Processing (3/6/08)

St. Jude Medical

• St. Jude Medical Riata defibrillator leads - Class 1 recall 12/14/11
• St. Jude Medical 6 French Engage™ Introducer Devices (8/13/2010)

Symbig

• Symbiq One and Two-Channel Infusers (9/22/2010)
• Symbiq One-Channel Infuser and Symbiq Two-Channel Infuser (07/15/2010)

T

Talecris

• Talecris recalls specific lots of Rh0(D) immune globulin (human) in the Pharmacy News section below. (05/01/2008)

Teleflex Medical

• Teleflex Medical issues urgent recall on Pilling coronary scissors (7/24/09)
• Teleflex issues urgent medical device recall on Weck brand ligating clips (9/25)
• Teleflex Medical issues voluntary recall on Hudson RCI large volume nebulizers (9/04/07)

Triad

Tri-anim

• Tri-anim Covidien Trach recall (4/8/09)
• Tri-anim announces recall on Promethazine HCL 25 mg/ml (10 ml count) (12/11/08)

Terumo

• Terumo Cardiovascular issues FDA recall and device removal notice for the CDI 101 Hematocrit/Oxygen Saturation Monitoring System 12/19/11
• Terumo issues alert on models 8000 and 9000 sarns perfusion systems with roller pumps: circuit board may malfunction (9/05/07)

U

Utah Medical

• Utah Medical Products recalls Intran Plus IUPC trays (6/19/2008)

V

Vanguard

• Vanguard issues recall for reprocessed trocar models (PP-OR-169) (4/10/06)

W

WalkMed

 

Z

Zimmer Orthopaedic

• Zimmer announces temporary and voluntary suspension of U.S. distribution of the Durom Cup® (8/28/2008)

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