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Medical Device Safety

Update – September 29, 2025

CDRH is expanding the Communications Pilot to Enhance the Medical Device Recall Program to include all medical devices. See the What is an Early Alert? webpage for additional information. 

The FDA monitors reports of adverse events and other problems with medical devices and when needed, alerts patients, health care providers, industry, and the public. The lists below contain our most recent information. For additional information, contact us – Division of Industry and Consumer Education (DICE).

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 Publish Date
Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication
Do Not Use Unauthorized Infant Devices for Monitoring Vital Signs: FDA Safety Communication
Do Not Use Unauthorized Devices for Measuring Blood Pressure: FDA Safety Communication

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.

Device Name Publish Date
Follow Instructions for Safe Use of Hyperbaric Oxygen Therapy Devices - Letter to Health Care Providers

MORE LETTERS TO HEALTH CARE PROVIDERS

Recent Medical Device Recalls and Early Alerts

Medical device recalls and early alerts about issues that may present significant risks. Note that early alerts include information on actions being taken by companies that the FDA believes are likely to be the most serious type of recall, but where the FDA may not yet have determined that the actions meet the regulatory definition of a recall. These actions may include when companies remove products from the market, correct products, or update instructions for using products due to potentially high safety risks.

Device Name Publish Date
Alert: Automated Impella Controller Correction due to Cybersecurity Issue from Abiomed
Recall and Alert Resources
What is an Early Alert?
Blood and Plasma Warming Device Correction: 3M Company Issues Correction for Ranger Blood/Fluid Warming System
Endoscopic Aspiration Needle Recall: Olympus Removes Certain ViziShot 2 FLEX (19G) Needles Due to Potentially Deformed A-traumatic Tips
Early Alert: Automated Impella Controller Purge Retainer Fixation Issue from Abiomed
Early Alert: TactiFlex Ablation Catheter Issue from Abbott
Electrical Wheelchair Component Correction: mo-Vis BVBA Issues Correction for R-net Joysticks Due to a Firmware Error
Early Alert: Medline Kits May Contain Recalled Medtronic Cardiac Cannulas
Insulin Pump Correction: Tandem Diabetes Care Issues Correction for Certain t:slim X2 Insulin Pumps Due to Risk for Faulty Speaker Wiring That May Cause Malfunction and Stop Insulin Delivery
Continuous Glucose Monitor Apps Correction: Dexcom, Inc. Issues Correction for G7 Apps and ONE+ Apps due to a Software Design Error That Does Not Alert Users of Unexpected Sensor Failure
Ventilator Recall: Philips Respironics Removes Certain DreamStation Devices Due to Programming Errors That Can Result in Failed Therapy Modes
Mobile Power Unit AC Power Cord Recall: Abbott Medical Removes AC Power Cord Associated with HeartMate Mobile Power Unit (MPU) Due to Potential Risk of the Cord Not Locking into Place
Breathing Circuit Set Recall: Hamilton Medical, Inc. Removes Coaxial Breathing Circuit Set Due to Possible Inner Blue Tube Cracks That May Impact Ventilation
Manual Resuscitator Recall: Ambu Inc. Removes SPUR II Resuscitators Due to Blocked Manometer Port
Ventilator Correction: Hamilton Medical AG Corrects HAMILTON-C6 Due to Risk of Ventilation Interruption from Defective Circuit Board
Applicator Recall: Integra LifeSciences Removes Extended Tip Applicator Due to Potential Sterility and Endotoxin Concerns
Infusion Pump Correction: ICU Medical, Inc. Issues Correction for Plum Duo Infusion System Due to Software Possibly Resulting in Pump Becoming Unresponsive
Vascular Stent Recall: Boston Scientific Removes Carotid WALLSTENT Monorail Endoprosthesis Due to Risk of Resistance During Device Withdrawal

MORE MEDICAL DEVICE RECALLS AND EARLY ALERTS

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