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 . [email protected]
Recent Medical Device Safety Communications
The FDA's 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.
Recent Medical Device Recalls
Medical device recalls that may potentially present significant risks to consumers or users of the product.
Medtronic Recalls HVAD Pump Implant Kit for Pump Weld Defect
Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms
Atrium Medical Corporation Recalls iCast Covered Stent for Potential Balloon or Catheter Hub Separation That May Cause Patient Harm
ArjoHuntleigh Polska Recalls Sara Plus Floor Lift for Risk of Smoke or Fire When Lift Is Used with Depleted Battery
Abbott Medical Recalls Dragonfly OpStar Imaging Catheter for Potential Loose Catheter Marker Band That May Cause Patient Harm
Woodside Acquisitions Inc. Recalls Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) That Are Not Authorized, Cleared, or Approved by the FDA
Avanos Medical Recalls Cortrak*2 Enteral Access System for Risk of Misplaced Enteral Tubes Could Cause Patient Harm
SML Distribution LLC Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA
Mesa Biotech, Inc., Recalls Certain Accula SARS-CoV-2 Tests for Risk of False Positives Caused by Contamination
Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Which May Have Been Distributed to Unauthorized, Non-CLIA-Certified Users
Medtronic Recalls Harmony Delivery Catheter, Part of Transcatheter Pulmonary Valve (TPV) System, for Risk of Capsule Break During Use
Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Labeled for Research Use Only
Philips Respironics Recalls Certain V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm
SD Biosensor Recalls STANDARD Q COVID-19 Ag Home Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results
Content current as of: