2012 Defective Product Recalls List

Here is a list of recent medical device recalls with links for more information.  Check back regularly for updates!

Device Name


Fresenius Medical Care North America, Naturalyte and Granuflo Acid Concentrate2 06/27/12
Nidek Medical Products, Inc., Mark 5 Nuvo, Nuvo 8 and Nuvo Lite Oxygen Concentrators3 06/21/12
SIGMA Spectrum Infusion Pump Model 35700 – Expanded Recall4 06/15/12
MOOG Medical Devices Group, Curlin Infusion Administration Sets5 05/31/12
Pharmaceutical Innovations, Inc, Other-Sonic Generic Ultrasound Transmission Gel6 05/30/12
Baxa Corporation Abacus Total Parenteral Nutrition (TPN) Calculation Software7 05/25/12
Roche Diagnostics Operations, Inc., Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays8 04/24/12
Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS)9 04/04/12
Acclarent Inspira AIR Balloon Dilation System, size 18X40mm.10 03/13/12
Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs)11 03/02/12
Flight Medical V24-00400-29 Cable for Newport HT50 Ventilator12 02/28/12
Nemschoff Chairs, Inc., Perinatal Pediatric Hospital Bed (Bassinet)13 02/24/12
Smiths Medical Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes14 02/23/12
CareFusion NicoletOne Software Used with CareFusion Cortical Stimulator Control Unit15 02/22/12
Salter Labs 7600 Bubble Humidifier Used with Supplemental Oxygen Therapy16 02/13/12
Respironics, Inc. Trilogy 100 Ventilators17 01/12/12
Ikaria INOmax DS Drug Delivery System18 01/04/12
CareFusion AVEA Ventilator19 12/23/11
St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads20 12/20/11
CooperVision AVAIRA Toric and Sphere Soft Contact Lenses21 12/09/11
Draeger Medical Inc., Infinity Acute Care System Monitoring Solution (M540)22 12/06/11