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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
Detachable Coil System Recall: J&J MedTech/CERENOVUS Inc. Remove CEREPAK Detachable Coil System
Early Alert: Heart Pump Issue from Abiomed
Early Alert: Insufflation Unit Issue from Olympus
Early Alert: Wound and Burn Dressing Issue from Integra LifeSciences
Early Alert: Stent and Electrocautery-Enhanced Delivery System Issue from Boston Scientific
Anesthetic Vaporizer Recall: Draeger Removes Vapor 2000 and Vapor 3000 Vaporizers
Anesthesia Kit Recall: Medline Removes Anesthesia Circuits and Anesthesia Circuit Kits
Early Alert: Broselow Rainbow Tape Issue from AirLife
Early Alert: Dialysis Tubing Set Issue from Vantive
Organ Recovery Pack Correction: AVID Medical Issues Correction for Medical Convenience and Organ Recovery Kits
Custom Surgical Pack Recall: Alcon Removes Custom Pak Ophthalmic Procedure Packs
Intravascular Administration Set Recall: ICU Medical Removes IV Gravity Burette Set
Continuous Glucose Monitoring Software Correction: Dexcom Issues Correction for Dexcom G6 and G6 Pro Software
Catheter Mount Recall: Draeger Removes ErgoStar Catheter Mounts
Endovascular Graft Recall: Cook Medical Removes Zenith Alpha 2 Thoracic Endovascular Graft
System Correction: IMPRIS Imaging Inc Issues Correction for IMRIS Neuro III-SV
Early Alert: Convenience Kit Needle Issue from Integra LifeSciences
Anesthesia System Correction: GE HealthCare Updates Use Instructions for CareStation Anesthesia Systems
Correction Alert: Olympus Updates Use Instructions for Ligating Device
Glucose Monitor Sensor Recall: Abbott Diabetes Care Removes Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors
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

MORE MEDICAL DEVICE RECALLS AND EARLY ALERTS

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