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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 [email protected].

Recent Medical Device Recalls

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

Device Name Publish Date
Arrow International, LLC (Subsidiary of Teleflex Inc.) Recalls the Arrow-Trerotola Percutaneous Thrombolytic Device Due to Risk of Tip Damage During Use
BASE10 Genetics Recalls RNAstill MTM Specimen Collection Kits That Are Not Authorized, Cleared, or Approved by the FDA, May Give False Results, and Require Special Training for Safe Handling
E25Bio Recalls COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results
Vyaire Medical Recalls bellavista 1000 and 1000e Series Ventilators Due to Issues with Software Configurations
Empowered Diagnostics Recalls COVID-19 Tests due to Risk of False Results
Philips Respironics Recalls Certain Trilogy EVO Ventilators for Potential Health Risks from PE-PUR Foam
Medtronic Inc. Recalls HawkOne Directional Atherectomy System Due to Risk of Tip Damage During Use
Getinge USA Sales, LLC Recalls the Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems Due to a Risk of Harmful Chemical Exposure
Cardiovascular Systems, Inc Recalls WIRION Embolic Protection Device Due to Complaints of Filter Breakage During Retrieval
Medtronic Recalls Synergy Cranial and StealthStation S7 Cranial Software Due to Potential Risk of Inaccurate Biopsy Depth Gauge Cycle View
2022 Medical Device Recalls
Covidien, LP Recalls Puritan Bennett 980 Series Ventilator Due to Manufacturing Assembly Error
Getinge/Datascope/Maquet Recalls Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Due to Reports of Fluid Leaks
Arrow International Inc Recalls Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7Fr, Due to Risk of Separation

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