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 Safety Communications
The FDA's analyses and recommendations for patients and health care providers about ongoing medical device safety issues.
FDA Safety Communication
FDA Warns People with Diabetes and Health Care Providers Against the Use of Devices for Diabetes Management Not Authorized for Sale in the United States: FDA Safety Communication 05/17/19
FDA Alerts Providers and Patients to Check for Premature Battery Depletion in Certain Medtronic Pacemakers: FDA Safety Communication 05/07/19
Mammography Problems at East Palestine Family Medical Clinic in East Palestine, Ohio: FDA Safety Communication 04/26/19
Use of the Stryker Wingspan Stent System Outside of Approved Indications Leads to an Increased Risk of Stroke or Death: FDA Safety Communication 04/25/19
The FDA Continues to Remind Facilities of the Importance of Following Duodenoscope Reprocessing Instructions: FDA Safety Communication 04/12/19
The FDA Recommends Only Using Cleared or Approved Medical Devices to Help Assess or Diagnose a Head Injury, Including Concussion: FDA Safety Communication 04/10/19
The FDA Warns Against Use of Previously Owned Test Strips or Test Strips Not Authorized for Sale in the United States: FDA Safety Communication 04/08/19
Cybersecurity Vulnerabilities Affecting Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors: FDA Safety Communication 04/03/19
UPDATE -- Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - Software Update for Potential Lack of Treatment (Shock) Delivery Due to Device Failure: FDA Safety Communication 03/18/19
Caution When Using Robotically-Assisted Surgical Devices in Women's Health including Mastectomy and Other Cancer-Related Surgeries: FDA Safety Communication 03/05/19
FDA Warns Thermography Should Not Be Used in Place of Mammography to Detect, Diagnose, or Screen for Breast Cancer: FDA Safety Communication 02/27/19
Intravascular Air-in-Line and Air Embolism Risks Associated with Infusion Pumps, Fluid Warmers, and Rapid Infusers: FDA Safety Communication 02/22/10
FDA Warns Against Use of Teething Necklaces, Bracelets, and Other Jewelry Marketed for Relieving Teething Pain or Providing Sensory Stimulation: FDA Safety Communication 02/15/19
MORE MEDICAL DEVICE SAFETY COMMUNICATIONS Recent Letters to Health Care Providers
Information for health care providers about the safe use of medical devices in medical facilities.
MORE LETTERS TO HEALTH CARE PROVIDERS Recent Medical Device Recalls
Medical device recalls that may potentially present significant risks to consumers or users of the product.
MORE MEDICAL DEVICE RECALLS
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