Notices in chronological order
of date issued
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.
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Archive (2006 through 2008)
Listing of notices in alphabetical order by manufacturer
December 2011
- Terumo Cardiovascular issues FDA recall and device removal notice for the CDI 101 Hematocrit/Oxygen Saturation Monitoring System 12/19/11
- St. Jude Medical Riata defibrillator leads - Class 1 recall 12/14/11
November 2011
- United States Surgical (Covidien) Issues a Voluntary Recall of specific lots of the LigaSurea Dolphin Tip Sealer/Divider 11/28/11
- 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
October 2011
- Integra Surgical issues a voluntary recall of the Luxtec Ultralite Pro headlight 10/28/11
- CareFusion 211 Inc. issues recall/notice on AVEA® ventilator, all models 10/11/11
September 2011
- Hospira Inc. is voluntarily recalling one lot of list number 7922-02 5% Dextrose Injection 9/14/2011
August 2011
- Ethicon Endo issues a voluntary recall of the ENDOPATH® ETS Compact Flex 45mm Articulating Linear Cutters 8/24/2011
- Alliant Healthcare Products issues recall on TruChoice products 8/8/2011
July 2011
- Mallinckrodt issues voluntary recall on all unexpired lots of MD-Gastroview contrast media in 120 mL and 240 mL bottles 7/29/2011
- Respironics Novametrix LLC has initiated a voluntary recall 7/29/2011
- Sigma issues recall on Spectrum Infusion Pump Model 35700 7/18/2011
- Covidien issues voluntary recall on all unexpired lots of MD-Gastroview contrast media in 120 mL and 240 mL bottles 7/13/2011
June 2011
- Baxter Healthcare Corporation issues recall on Potassium Chloride Injection 6/29/2011
- Ansell Healthcare Issues a voluntary recall on the Encore Underglove 6/19/2011
May 2011
- Beckman Coulter issues Class I Recall on Synchron® LX® 20, LX 20 PRO, LXi 725 Clinical Systems 5/27/11
- Non-Sterile Boston Scientific Devices Stolen Endoscopy and Urology / Women's Health Devices 5/3/11
April 2011
- BD Diagnostics issues Class II Recall on BD Vacutainer Push Button Blood Collection Set 4/22/11
March 2011
- Hospira issues nationwide recall alert on 0.9% Sodium Chloride Injection USP in 1000 mL Lot # 95-070-JT 3/30/11
- Moog Medical Devices Group Issues Urgent Medical Device Recall
February 2011
- Gaymar Industries issues recall on certain products experiencing design problems with the power cords 2/16/2011
- Ethicon issues voluntary recall on Dermabond Topical Skin Adhesive products 2/16/2011
- Baxter issues urgent device correction on AUTOMIX compounder 2/16/2011
- Davol Inc. issues voluntary recall on XenMatrix Surgical Graft 2/16/2011
- Abbott Glucose Test Strips 02/15/11
- Triad Group, Triad Sterile Lubricating Jelly 02/15/11
- Cardinal Health 200 Inc. communicates recall of Triad prodcuts 02/09/11
- Arstasis One Access System 02/09/11
- Merit Medical Systems Prelude Short Sheath Catheter Introducer 02/04/11
January 2011
- B. Braun, Outlook 400ES Safety Infusion System, Model Number 621-400ES 01/31/11
- Arrow Ultra 8 Intra-Aortic Balloon Catheters (IABS) 8 FR 30CC and 40CC Universal and Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and Measurement System: UPDATE 01/26/2011 01/26/11
- Fresenius Medical Care North America, CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for Use with the Blood Volume Monitor 01/20/11
- MAI Recall Letter 1/19/11
- Medical Action issues alert for products included in IV Site Management and accessories kits and trays 1/19/11
- AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon CatheterOTW 0.018" Platform (multiple sizes) 01/05/11
December 2010
- ev3 NanoCross .014" OTW PTA Dilatation Catheter 12/28/10
- Fresenius Kabi LLC, Red Blood Cell (RBC) Exchange Sets used on AS104 Blood Cell Separation Devices 12/21/10
- Penumbra System Reperfusion Catheter 032 12/08/10
November 2010
- Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps - Recall, Refund and Replacement 11/30/10
- B. Braun addEASE Binary Connector 11/30/10
- WalkMed, Inc. Triton Pole Mount Infusion Pump 11/24/10
- Micromedics, Inc., Surgical Sealant Dispensers, Micromedics Nasal Septal Buttons, and Otological Ventilation Tubes – Sealed in Pouches 11/23/10
- SIGMA Spectrum Infusion Pump Model 3570 11/12/10
- BioMerieux, Inc., VITEK 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam (TZP) 11/10/10
- Hospira Symbiq One and Two Channel Infuser 11/04/10
- Medtronic Octopus Nuvo Tissue Stabilizer, Model TSMICS1 11/02/10
October 2010
- Excelsior Medical Disposable Syringe with Normal Saline (0.9% Sodium Chloride, 5mL fill in 6mL syringe) 10/26/10
- CareFusion Corporation, Alaris PC Units (Model 8015) 10/15/10
- Westmed Inc., BagEasy Manual Resuscitation Devices 10/13/10
- Multi-Med, Inc. Huber (Non-coring) Needles and Finished Devices Containing Huber Needles Labeled as "All-Med Medical Products, Inc." and "Marquette Medical, Inc." Brands and Provided to Some Consignees in Bulk Without Labeling 10/12/10
September 2010
- Sigma issues recall on Spectrum Infusion Pump Model 35700 (9/29/2010)
- Symbiq One and Two-Channel Infusers (9/22/2010)
- Cardinal Health issues a recall for Medi-Vac Non-Conductive Tubing (9/8/2010)
- Integra NeuroSciences issues recall on Integra Neuroballon Catheters (Catalog number 7CBD10) (9/2/2010)
- Hospira Inc. issues recall on specific lots of GemStar pump sets (9/1/2010)
- Medela Inc. issues a recall for certain hospital kit products (9/1/2010)
August 2010
- 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)
- Ikaria Holdings, INOMAX DS Drug Delivery System (8/23/2010)
- St. Jude Medical 6 French Engage™ Introducer Devices (8/13/2010)
- 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)
July 2010
- Alcon Research LTD doing business as Alcon Laboratories, Inc. - CONSTELLATION Vision System (07/20/2010)
- Symbiq One-Channel Infuser and Symbiq Two-Channel Infuser (07/15/2010)
- Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System (07/02/2010)
- Physio-Control Inc., LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors (07/02/2010)
June 2010
- Manufacturer Recalls Disinfecting Equipment After Failure To Properly Sterilize Device (6/25/2010)
- FDA - Class I Recall and Safety Investigation of Counterfeit Polypropylene Surgical Mesh (6/10/2010)
April 2010
- ConMed issues recall on ConMed GoldLine rocker switch pencils, contained in Avid custom procedure trays (4/30/10)
- Covidien issues a voluntary recall of cuffed Shiley™ tracheostomy products (4/30/10)
February 2010
- Baxter Healthcare Corporation issues recall on Y-Type Blood Solution Sets, Product Code 2C8750 (2/25/2010)
- Medtronic USA issues notice on Concerto® and CRT-D and Virtuoso ICD® devices (2/25/2010)
- Smiths Medical ASD Inc. issues recall on Medfusion® syringe infusion pumps, models 3010A and 3500 (2/25/2010)
- Bard Electrophysiology issues recall on Bard Channel FX Transseptal Sheath Kit (2/17/2010)
- Becton, Dickinson and Company issues recall on Nexiva™ Closed IV Catheter System (2/17/2010)
- United States Surgical (Covidien) issues a voluntary recall of the ProTack™ fixation device (2/17/2010)
- Kimberly-Clark Health Care receives an updated 510(k) clearance to market the KC300 KimGuard One-Step (2/17/2010)
- FDA grants 18-month extension to facilities transitioning from STERIS System 1 to an alternative device (2/17/2010)
- Bard Access Systems, Inc. issues recall on HuberPlus™ Non-Coring Needle Safety Infusion Sets (2/17/2010)
- FDA extends Steris System I transition time to 18 months (2/2/10)
January 2010
- Baxter Healthcare Corporation issues recall on Y-Type Blood Solution Sets, Product Code 2C8750 (1/14/10)
- U.S Food and Drug Administration issues notification and recommendations on Steris System 1 processor (1/14/10)
- Medtronic USA issues notice on Concerto and CRT-D and Virtuoso ICD devices (1/14/10)
December 2009
- Baxa Corporation issues recall on ExactaMix TPN Bags (12/03/09)
- CareFusion issues notice on iodine based products (12/03/09)
October 2009
- Medtronic USA issues notice on Concerto® and CRT-D and Virtuoso ICD® devices (10/15/09)
- Smiths Medical issues voluntary recall on Portex® Pediatric Tracheal Tubes (10/15/09)
September 2009
- Smiths Medical issues voluntary recall on Portex Pediatric Tracheal Tubes (9/24/09)
- Medtronic USA issues notice on Concerto® and CRT-D and Virtuoso ICD devices (9/24/09)
- Hospira Inc. issues recall on AC power cords (9/08/09)
- Covidien issues update on global molybdenum 99 (Mo99) supply situation (9/02/09)
- CareFusion Corporation issues recall/notice update on recall of the Alaris system (9/02/09)
August 2009
- Medtronic issues wire separation notice regarding subsets of Kappa® and Sigma® pacemakers (8/12/09)
- Abbott Vascular issues voluntary device recall on POWERSAILA® Coronary Dilation Catheters (8/12/09)
- 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)
July 2009
- Medtronic issues wire separation notice regarding subsets of Kappa® and Sigma® pacemakers (7/24/09)
- Edward Life Sciences issues recall on Fogarty Occlusion Catheter (7/24/09)
- Teleflex Medical issues urgent recall on Pilling coronary scissors (7/24/09)
June 2009
- Smith & Nephew Endoscopy issues voluntary recall of DYONICS 25 tubeset kits (6/25/09)
- Leonhard Lang USA issues urgent medical device recall for Skintact DF20 Defibrillation Electrodes (6/25/09)
May 2009
- Ansell Healthcare issues a voluntary recall on Derma Prene Ultra Surgical Gloves (5/23/09)
- Ethicon Endo-Surgery expands recall of ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters (5/14/2009)
- Bard Electrophysiology discontinues original woven catheter end items, introduces new SURELINK© cable connector with replacement product (5/6/09)
- Covidien's Kangaroo ePump™ and Kangaroo Joey™ enteral feeding sets may experience priming problems (5/6/09)
- Cardinal Health to discontinue latex gloves (5/6/09)
- Maquet issues device correction on PRISMATIC triple surgical lights (5/6/09)
- Cardinal Health issues urgent safety alert regarding therapy feature used with Alaris PCA module (model 8120) (5/6/09)
- Liko initiates corrective program on Uno Patient Lift (5/6/09)
- Olympus issues reminder to reprocess MAJ-855 Auxiliary Water Tube following endoscopy procedures (5/6/09)
- Update: Covidien's alert on the Shiley 3.0 PED cuffless pediatric tracheostomy tube has been upgraded to a voluntary recall (5/6/09)
April 2009
- B. Braun issues a recall on specific lots of IV Sets (4/8/09)
- Tri-anim Covidien Trach recall (4/8/09)
March 2009
- Smiths Medical recalls Medfusion Syringe Infusion Pumps and Spare Part Kits (3/18/09)
- Welch Allyn recalls AED 10 and MRL JumpStart defibrillators (3/18/09)
- Arrow International recalls 30/40/50 CC IAB Volume Connectors (3/18/09)
- Olympus issues reminder to reprocess MAJ-855 Auxiliary Water Tube (03/09)
February 2009
- Edwards Lifesciences issues recall on "Swan-Ganz Continuous Cardiac Output (CCO)" Catheters (2/26/2009)
- Ethicon recalls multiple lots of absorbable sutures (2/18/2009)
- Arrow International recalls 30/40/50 CC IAB Volume Connectors (2/17/2009)
- Ethicon Endo-Surgery issues a recall on ENDOPATH® ETS-Flex45 Endoscopic Articulating Linear Cutters [Product Code ATS45](2/17/2009)