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 |
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
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09/25/12
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I-Flow ON-Q Pump with ONDEMAND Bolus Button
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08/31/12
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Baxter Healthcare Corporation, Automix Automated Nutrition Compounder Systems
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08/29/12
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CareFusion Alaris Pump Module, Model 8100 – Motor Stall
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08/23/12
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CareFusion Alaris Pump Module, Model 8100 – Keyboard Overlay
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08/22/12
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Synthes Hemostatic Bone Putty
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08/21/12
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Certain Covidien Shiley Adult Tracheostomy Tubes
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08/15/12
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Smiths Medical Medfusion Model 4000 Syringe Infusion Pump
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08/02/12
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Respironics, Inc., Trilogy 100, 200, and 202 Ventilators
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08/02/12
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B. Braun Infusomat Space Infusion System – Expansion of Recall from January, 2012
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08/01/12
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CareFusion Alaris PC Unit, Model 8015
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08/01/12
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Arrow International, Inc. (subsidiary of Teleflex, Inc.), Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter
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07/30/12
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CareFusion EnVe Ventilators (Distributed 12/2010 - 05/2012)
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07/20/12
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Maquet Medical Systems USA, FLOW-i Anesthesia System (software)
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07/11/12
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Alere, Triage (Multiple Tests)
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07/11/12
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GE Healthcare, LLC, Aestiva/5 7900 Ventilator
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07/11/12
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CareFusion 2200 Inc., Care Fusion Airlife Infant Breathing Circuit
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07/06/12
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Fresenius Medical Care North America, Naturalyte and Granuflo Acid Concentrate
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06/27/12
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Nidek Medical Products, Inc., Mark 5 Nuvo, Nuvo 8 and Nuvo Lite Oxygen Concentrators
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06/21/12
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SIGMA Spectrum Infusion Pump Model 35700 - Expanded Recall
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06/15/12
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MOOG Medical Devices Group, Curlin Infusion Administration Sets
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05/31/12
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Pharmaceutical Innovations, Inc, Other-Sonic Generic Ultrasound Transmission Gel
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05/30/12
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Baxa Corporation Abacus Total Parenteral Nutrition (TPN) Calculation Software
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05/25/12
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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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