2011 Medical Devices Recalled by the FDA

2011 Medical Device Recalls

Listed by date posted on the FDA Website

Device Name


CareFusion AVEA Ventilator2 12/23/11
St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads3 12/20/11
CooperVision AVAIRA Toric and Sphere Soft Contact Lenses4 12/09/11
Draeger Medical Inc., Infinity Acute Care System Monitoring Solution (M540)5 12/06/11
King International LLC., ShoulderFlex Deep-kneading Shiatsu Massager6 11/16/11
Mizuho OSI Modular Table Systems7 11/09/11
CareFusion EnVe Ventilators8 11/04/11
Lee Medical International Inc., Custom Dialysis Trays / Kits9 10/03/11
Lee Medical International Inc., Custom Dialysis Trays/Kits10 09/16/11
Medtronic Model 8637 SynchroMed II Implantable Infusion Pump11 09/12/11
GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH) for Vital Signs Anesthesia Breathing Circuits12 08/03/11
Arrow International, Inc. Arrow NextStep Antegrade Chronic Hemodialysis Catheter13 08/03/11
GEM Premier 4000 PAK Cartridges for Use on the GEM Premier 4000 System14 08/01/11
Global Focus Marketing & Distribution, Ltd., Silencer® S2200 Centrifuge15 07/27/11
Roche Diagnostics Operations, ACCU-CHEK Performa Strip16 06/20/11
Boston Scientific Innova Self-Expanding Stent System17 06/16/11
Churchill Medical Systems, a Vygon Company, Skin-Prep Wipes Used in Convenience Kits and Tray18 06/15/11
Maquet Datascope Corp. Intra-Aortic Balloon Pumps19 06/14/11
Terumo Coronary Ostia Cannula 10, 12, 14 Fr20 06/14/11
Boston Scientific iCross and Atlantis SR Pro 2 Coronary Imaging Catheters21 06/14/11
Oridion Medical and Philips Healthcare Microstream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate)22 06/06/11
Beckman Coulter, Inc., Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell23 05/23/11
Defibtech LLC, Lifeline and ReviveR AEDs: Software Defect May Cancel Shock24 05/10/11
bioMérieux, Inc., VITEK® 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam (TZP2) – Expanded Recall25 05/03/11
Penumbra Inc., Penumbra Coil 40026 04/13/11
iCAD (formerly Xoft Inc.), Axxent® FlexiShield Mini, Model F530027 04/13/11
Millar Instruments Inc., Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F28 03/31/11
Maquet Cardiovascular, LLC, Heartstring II Proximal Seal System (HS-1045)29 03/31/11
Roche Insulin Delivery Systems, ACCU-CHEK FlexLink Plus Infusion Sets30 03/29/11
Gen-Probe Inc., AccuProbe Group B Streptococcus Culture Identification Test, AccuProbe Mycobacterium Tuberculosis Complex Culture Identification Test, and AccuProbe Mycobacterium Avium Complex Culture Identification Test31 03/17/11
Davol Inc., XenMatrix Surgical Graft32 03/04/11
Cook Inc., Single, Double, Triple and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripheral Inserted Central Venous Catheter Trays33 03/03/11
Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits34 02/16/11
Abbott Glucose Test Strips35 02/15/11
Triad Group, Triad Sterile Lubricating Jelly36 02/15/11
Arstasis One Access System37 02/09/11
Merit Medical Systems Prelude Short Sheath Catheter Introducer38 02/04/11
B. Braun, Outlook 400ES Safety Infusion System, Model Number 621-400ES39 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 01/26/201140 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 Monitor41 01/20/11
AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon CatheterOTW 0.018″ Platform (multiple sizes)42 01/05/11