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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 Letters to Health Care Providers

Information for health care providers about the safe use of medical devices in medical facilities.

Device Name Publish Date
Disruptions in Availability of Breast Biopsy Needles - 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
Positive Pressure Breathing Device Correction: Baxter Issues Correction for Volera Positive Pressure Breathing Devices
Heart Pump Correction: Abiomed Issues Correction for Automated Impella Controllers
Convenience Kit Correction: Medline Issues Correction for Kits Containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP
Convenience Kit Correction: Windstone Medical Packaging, Inc. Issues Correction for Convenience Kit
Catheter Introducer Correction: Abiomed and Oscor Issue Correction for Catheter Introducer
First Aid Kit Recall: North American Rescue Issues Correction for First Aid Kits Containing TRUE METRIX Devices
Infusion Pump Correction: Fresenius Kabi Issues Correction for dropped or jarred Ivenix Large Volume Infusion Pumps
Infusion Pump Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Infusion Pump
Convenience Kit Correction: Medical Action Industries Issues Correction for Kits Containing Recalled Namic Manifolds
Convenience Kit Correction: Medline Issues Correction for Convenience Kits Containing BD ChloraPrep Applicators
Pulmonary Valve Catheter Delivery System Recall: Medtronic Removes Harmony Delivery Catheter System (DCS)
Ventilator Correction: Resmed Issues Correction for Astral Ventilator
Convenience Kit Recall: B. Braun Medical, Inc. Removes Spinal Anesthesia Kits Containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP
Convenience Kit Correction: Arrow International Issues Correction for Convenience Kits Containing Recalled Huons Lidocaine and Bupivacaine and Saline
Intravascular Administration Set Recall: Baxter Removes Duo-Vent Solution Sets
Percutaneous Catheter Recall: Boston Scientific Removes ENROUTE Transcarotid Neuroprotection System
Convenience Kit Correction: Argon Medical Issues Correction for Convenience Kits Containing Spectra Medical Device Lidocaine Ampules
Convenience Kit Correction: Medline Issues Correction for Kits Containing Huons Lidocaine Hydrochloride and Bupivacaine Hydrochloride in Dextrose Injection
Intraosseous Needle Set Recall: Becton Dickinson Removes Certain Intraosseous Vascular Access System Needle Sets
Convenience Kit Correction: Medline Issues Correction for Convenience Kits Containing ICU Medical Pain Management Components
Early Alert: Convenience Kit Issue from Becton Dickinson
Convenience Kit Recall: Medline Issues Correction for Convenience Kits Containing B. Braun Bupivacaine Hydrochloride Components
Early Alert: Epidural Kit Issue from Medical Action Industries
Breathing Circuit Recall: Medline Removes Neonatal and Infant Heated Wire Breathing Circuits
Monitoring System Correction: GE HealthCare Updates Use Instructions for Portrait Core Services Software

MORE MEDICAL DEVICE RECALLS AND EARLY ALERTS

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