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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
Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health: 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
Disruptions in Availability of Breast Biopsy Needles - Letter to Health Care Providers
Disruptions in Availability of Neurosurgical Patties, Sponges, and Strips - 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
Early Alert: Percutaneous Catheter Issue from Boston Scientific
Early Alert: Intravascular Administration Set Issue from Baxter
Convenience Kit Correction: Arrow International Issues Correction for Convenience Kits Containing Recalled Huons Lidocaine and Bupivacaine and Saline
Convenience Kit Recall: B. Braun Medical, Inc. Removes Spinal Anesthesia Kits Containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP
Early Alert: Ventilator Issue from Resmed
Pulmonary Valve Catheter Delivery System Recall: Medtronic Removes Harmony Delivery Catheter System (DCS)
Early Alert: Convenience Kits Issue from Medline
Early Alert: Convenience Kit Issue from Medical Action Industries
Infusion Pump Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Infusion Pump
Infusion Pump Correction: Fresenius Kabi Issues Correction for dropped or jarred Ivenix Large Volume Infusion Pumps
First Aid Kit Recall: North American Rescue Issues Correction for First Aid Kits Containing TRUE METRIX Devices
Early Alert: Catheter Introducer Issue from Abiomed and Oscor
Convenience Kit Correction: Windstone Medical Packaging, Inc. Issues Correction for Convenience Kit
Convenience Kit Correction: Medline Issues Correction for Kits Containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP
Heart Pump Correction: Abiomed Issues Correction for Automated Impella Controllers
Positive Pressure Breathing Device Correction: Baxter Issues Correction for Volera Positive Pressure Breathing Devices
Breathing Circuit Set Correction: Hamilton Medical Updates Use Instructions for Breathing Circuit Set
Infant Resuscitation System Correction: GE HealthCare Issues Correction for Giraffe and Panda Infant Resuscitation Systems and Warmers with a M1091607-R Blender
Insulin Pump Recall: Insulet Removes Omnipod Pods
Anesthesia Kit Correction: Becton Dickinson Issues Correction for BD Spinal Trays Containing Bupivacaine Ampules
Catheter Introducer Kit Recall: Abiomed Removes 14Fr Low Profile Introducer Kits
Pediatric Care Bed Correction: KayserBetten Issues Correction for KayserBett IDA Beds
Early Alert: IV Tubing Set Issue from ICU Medical
Heart Pump Recall: Abiomed Removes Impella CP Sets with SmartAssist
Manifold Recall: Medline Removes Namic Star Off Handle Manifolds 

MORE MEDICAL DEVICE RECALLS AND EARLY ALERTS

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