2012 Medical Device Recalls

Listed by date posted on the FDA Website

Device Name	Date
GE Healthcare T-Piece Circuits for the Giraffe and Panda Resuscitation Systems	12/28/12
Zimmer Spine, Inc. - PEEK Ardis Inserter	12/28/12
Ventlab Corporation Adult and Pediatric Manual Resuscitators	12/21/12
Bunnell Incorporated, Life Pulse High-Frequency Ventilator Patient Circuits	12/21/12
Medtronic SynchroMed II Implantable Drug Infusion Pump and SynchroMed EL Implantable Drug Infusion Pump	12/21/12
Ethicon, Inc., SURGIFLO Hemostatic Matrix and SURGIFLO Hemostatic Matrix Kit Plus FlexTip with Thrombin	12/13/12
Verathon, Inc., Certain GlideScope Video Laryngoscope Reusable Blades	12/12/12
Natus Medical Incorporated, Olympic Cool-Cap System (Revised)	12/12/12
Mindray A3 and A5 Anesthesia Delivery System	11/30/12
HeartSine Samaritan Public Access Defibrillator 300/300P	11/19/12
Baxter Healthcare Corporation, Buretrol Solution Sets	11/08/12
Touchscreen for Hospira Symbiq Infusion System, Models 16026 and 16027	10/26/12
Ethicon Endo-Surgery, Inc. Proximate PPH Hemorrhoidal Circular Stapler and Accessories 33mm, Proximate HCS Hemorrhoidal Circular Stapler and Accessories 33mm and the Transtar Circular Stapler Procedure Set	10/24/12
Stryker Instruments, Neptune Rover Waste Management Systems	10/24/12
Accutron, Inc. Ultra PC% Cabinet Mount Flowmeters for Nitrous Oxide-Oxygen Sedation Systems	10/16/12
Custom Medical Specialties, Inc., Custom HSG Tray, Hysteroscopic Sterilization Pack, Custom Vein Tray, Custom Amnio Tray, Fox Chase Specials Pack, Abington Radiology Drainage Pack, Custom CT Biopsy Tray, HSG Tray, Custom Myelogram Tray, and Hysteroscopy Sterile Procedure Kit	09/25/12
I-Flow ON-Q Pump with ONDEMAND Bolus Button	08/31/12
Baxter Healthcare Corporation, Automix Automated Nutrition Compounder Systems	08/29/12
CareFusion Alaris Pump Module, Model 8100 – Motor Stall	08/23/12
CareFusion Alaris Pump Module, Model 8100 – Keyboard Overlay	08/22/12
Synthes Hemostatic Bone Putty	08/21/12
Certain Covidien Shiley Adult Tracheostomy Tubes	08/15/12
Smiths Medical Medfusion Model 4000 Syringe Infusion Pump	08/02/12
Respironics, Inc., Trilogy 100, 200, and 202 Ventilators	08/02/12
B. Braun Infusomat Space Infusion System – Expansion of Recall from January, 2012	08/01/12
CareFusion Alaris PC Unit, Model 8015	08/01/12
Arrow International, Inc. (subsidiary of Teleflex, Inc.), Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter	07/30/12
CareFusion EnVe Ventilators (Distributed 12/2010 - 05/2012)	07/20/12
Maquet Medical Systems USA, FLOW-i Anesthesia System (software)	07/11/12
Alere, Triage (Multiple Tests)	07/11/12
GE Healthcare, LLC, Aestiva/5 7900 Ventilator	07/11/12
CareFusion 2200 Inc., Care Fusion Airlife Infant Breathing Circuit	07/06/12
Fresenius Medical Care North America, Naturalyte and Granuflo Acid Concentrate	06/27/12
Nidek Medical Products, Inc., Mark 5 Nuvo, Nuvo 8 and Nuvo Lite Oxygen Concentrators	06/21/12
SIGMA Spectrum Infusion Pump Model 35700 - Expanded Recall	06/15/12
MOOG Medical Devices Group, Curlin Infusion Administration Sets	05/31/12
Pharmaceutical Innovations, Inc, Other-Sonic Generic Ultrasound Transmission Gel	05/30/12
Baxa Corporation Abacus Total Parenteral Nutrition (TPN) Calculation Software	05/25/12
Roche Diagnostics Operations, Inc., Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays	04/24/12
Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS)	04/04/12
Acclarent Inspira AIR Balloon Dilation System, size 18X40mm.	03/13/12
Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs)	03/02/12
Flight Medical V24-00400-29 Cable for Newport HT50 Ventilator	02/28/12
Nemschoff Chairs, Inc., Perinatal Pediatric Hospital Bed (Bassinet)	02/24/12
Smiths Medical Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes	02/23/12
CareFusion NicoletOne Software Used with CareFusion Cortical Stimulator Control Unit	02/22/12
Salter Labs 7600 Bubble Humidifier Used with Supplemental Oxygen Therapy	02/13/12
Respironics, Inc. Trilogy 100 Ventilators	01/12/12
Ikaria INOmax DS Drug Delivery System	01/04/12