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The FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when needed to ensure proper use of devices and the health and safety of patients. The lists below contain our most recent information. Other safety communications can be found using the links on the left side of this page. For additional information, contact us at: 1-800-638-2041 or DICE@fda.hhs.gov.

Recent Medical Device Recalls

Medical device recalls that may potentially present significant risks to consumers or users of the product.

Device Name Publish Date
LivaNova (TandemLife) Recalls LifeSPARC System for Risk of Unintentional Extended Pump Stop During Controller Critical Failure
Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern
Baxter Healthcare Corporation Recalls Clearlink Basic Solution Set with Duovent for Risk of Leaks That May Expose Providers and Patients to Hazardous / Toxic Substances
Medtronic Recalls NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube for Risk of Airway Obstruction
Hamilton Medical AG Recalls Hamilton-C6 Intensive Care Ventilator Due to Potential Water Ingress that May Cause Breathing Support to Stop
Intera Oncology Recalls Intera 3000 Hepatic Artery Infusion Pump Due to Faster Than Expected Flow Rates That May Impact Infusion Delivery
Medtronic Recalls HeartWare HVAD System Batteries for Electrical Faults That Cause Battery Failure
Medtronic Recalls Cobalt XT, Cobalt and Crome ICDs and CRT-Ds for Risk that Devices May Issue a Short Circuit Alert and Deliver Reduced Energy Shock During High Voltage Therapy
Becton Dickinson Recalls Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, and Intraosseous Powered Drivers for Issues That May Cause Delayed Treatment Delivery
Haimen Shengbang Laboratory Equipment Co. Ltd. Recalls Viral Transport Media Containers That Are Not Authorized, Cleared, or Approved by the FDA
North American Diagnostics Recalls Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits That Are Not Authorized, Cleared, or Approved by the FDA
Covidien, LLC (Medtronic) Recalls Palindrome and Mahurkar Hemodialysis Catheters Due to Catheter Hub Defect
Baxter Healthcare Corporation Recalls Abacus Order Entry and Calculation Software for Risk of Medication Label Errors
Smiths Medical Recalls Certain Medfusion 3500 and 4000 Syringe Infusion Pumps for Software Issues That May Impact Infusion Delivery
American Contract Systems Recalls COVID Test Kits Nonsterile and Clean Catch Urine Kits for Risk of False Results

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