Medical Devices
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List of Device Recalls
FDA posts consumer information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death.
Use the yearly lists to find information about Class I medical device recalls and some Class II and III recalls of interest to consumers. The links give details about what to do if you own or use one of these products.
Please note that FDA now lists medical device recall notices by the date that it posts the recall rather than the recall initiation date. You can find the date that a firm initiated a recall in the text of the recall notice.
Recent Medical Device Recalls
Listed by date posted on FDA website.
| Device Name | Date |
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Roche Diagnostics Operations, Inc., Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays
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04/24/12
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Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS)
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04/04/12
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Acclarent Inspira AIR Balloon Dilation System, size 18X40mm.
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03/13/12
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Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs)
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03/02/12
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Flight Medical V24-00400-29 Cable for Newport HT50 Ventilator
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02/28/12
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Nemschoff Chairs, Inc., Perinatal Pediatric Hospital Bed (Bassinet)
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02/24/12
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Smiths Medical Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes
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02/23/12
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CareFusion NicoletOne Software Used with CareFusion Cortical Stimulator Control Unit
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02/22/12
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Salter Labs 7600 Bubble Humidifier Used with Supplemental Oxygen Therapy
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02/13/12
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Respironics, Inc. Trilogy 100 Ventilators
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01/12/12
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Ikaria INOmax DS Drug Delivery System
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01/04/12
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CareFusion AVEA Ventilator
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12/23/11
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St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads
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12/20/11
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CooperVision AVAIRA Toric and Sphere Soft Contact Lenses
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12/08/11
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Draeger Medical Inc., Infinity Acute Care System Monitoring Solution (M540)
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12/06/11
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King International LLC., ShoulderFlex Deep-kneading Shiatsu Massager
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11/16/11
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Mizuho OSI Modular Table Systems
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11/09/11
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CareFusion EnVe Ventilators
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11/04/11
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Lee Medical International Inc., Custom Dialysis Trays/Kits
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10/03/11
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Lee Medical International Inc., Custom Dialysis Trays/Kits
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09/16/11
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Medtronic Model 8637 SynchroMed II Implantable Infusion Pump
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09/12/11
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