1. Home
  2. Medical Devices
  3. Medical Device Safety
  1. Medical Devices

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 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
Early Alert: Anesthesia System Issue from GE HealthCare
Correction Alert: Olympus Updates Use Instructions for Ligating Device
Early Alert: Glucose Monitor Sensor Issue from Abbott Diabetes Care
Recall Alert: Glycar SA Removes Pericardial Patch
Correction Alert: Becton Dickinson Updates Use Instructions for BD Alaris Pump Issue
Recall Alert: Baxter Permanently Removes Life2000 Ventilation System
Recall Alert: BALT USA Removes MEGA Ballast Distal Access Platform
Recall Alert: Max Mobility/Permobil Removes All SpeedControl Dials Used with SmartDrive MX2+ Power Assist Devices
Early Alert: Large Volume Pump Primary Administration Set Reverse Flow Issue from Fresenius Kabi
Recall Alert: Intersurgical Inc Removes i-View Video Laryngoscope
Correction Alert: Medline Industries, LP Updates Use Instructions for Medline Kits Containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles
Alert: NOxBOX Ltd. Issues Correction for NOxBOXi Nitric Oxide Delivery System Due to Rapid Command Input Issue
Alert: NOxBOX Ltd. Issues Correction for NOxBOXi Nitric Oxide Delivery System Due to Risk for Nitric Oxide Dosing Fluctuations
Alert: Medline Industries, LP Removes Certain Sterile Medline Convenience Kits
Alert: Siemens Healthineers Issues Correction for 3 Tesla MRI Systems
Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set
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

MORE MEDICAL DEVICE RECALLS AND EARLY ALERTS

Subscribe to Medical Device Safety and Recalls

Sign up to receive email updates on medical device recalls, safety communications, and other safety information.
Back to Top