Medical Devices
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Medical Device Safety
FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when needed to ensure proper use of devices and the health and safety of patients. The lists below show recent medical device recalls and other FDA safety communications. Other safety communications can be found using the links on the left side of this page. For additional information, contact us at: 1-800-638-2041 or dsmica@fda.hhs.gov.
Recent Medical Device Recalls
Device Name |
Date Posted |
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 |
Respironics, Inc., Trilogy 100, 200, and 202 Ventilators |
08/02/12 |
Smiths Medical Medfusion Model 4000 Syringe Infusion Pump |
08/02/12 |
CareFusion Alaris PC Unit, Model 8015 |
08/01/12 |
B. Braun Infusomat Space Infusion System – Expansion of Recall from January, 2012 |
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 |
GE Healthcare, LLC, Aestiva/5 7900 Ventilator |
07/11/12 |
Maquet Medical Systems USA, FLOW-i Anesthesia System (software) |
07/11/12 |
Alere, Triage (Multiple Tests) |
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 |
Recent Medical Device Safety Communications
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