The 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 contain our most recent information. 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 DICE@fda.hhs.gov.
Recent Medical Device Recalls
Summaries of medical device recalls that may potentially present significant risks to consumers or users of the product.
|Medtronic Recalls StrataMR Adjustable Valves and Shunts Which May Cause Fluid Buildup in the Brain||04/19/17|
|Merit Medical Systems, Inc. Recalls the Prelude® Short Sheath Introducer - Sheath May Separate During Use||03/30/17|
|Phillips Healthcare recalls HeartStart MRx Monitor/Defibrillator due to electrical issues that may prevent the device from operating properly||03/24/17|
|Medtronic Recalls SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps Due to Failure of Priming Bolus – Update Related to May 2013 Recall||03/14/17|
|Physio-Control Inc. Recalls LIFEPAK 1000 Defibrillator Due to an Electrical Issue Which May Cause the Device to Shut Down Unexpectedly||03/08/17|
|Zimmer Biomet Recalls Comprehensive Reverse Shoulder due to a High Fracture Rate||02/15/17|
|Physio-Control Recalls LIFEPAK15 Monitor/Defibrillator Due to Failure of Electrical Shock Delivery||02/10/17|
|CareFusion Recalls Alaris Pump Module due to an Alarm Error Which May Cause Interruption of Therapy||02/08/17|
Recent Medical Device Safety Communications
FDA analyses and recommendations for patients and health care providers about ongoing medical device safety issues.
Recent Letters to Health Care Providers
Information for health care providers about the safe use of medical devices in medical facilities.
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