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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 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
Infusion Pump Recall: Fresenius Kabi Removes Ivenix Large Volume Pumps
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
MRI System Correction: Siemens Healthineers Issues Correction for 3 Tesla MRI Systems
Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set

MORE MEDICAL DEVICE RECALLS AND EARLY ALERTS

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