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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.

Recent Medical Device Recalls

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

Device Name Publish Date
Becton Dickinson (BD)/Carefusion 303 Recalls Alaris Infusion Pumps Due to Compatibility Issues with Cardinal Health Monoject Syringes
Eitan Medical Ltd Recalls Sapphire Infusion Pumps for Failure to Detect Air in the Line
Unomedical A/S Recalls VariSoft Infusion Sets Due to Damage to the Connector Piece Causing Unexpected Disconnections
B. Braun Medical, Inc. Recalls Infusomat Space Large Volume Pump, Wireless and Infusomat Space Large Volume Pump, Non-Wireless BATTERY PACK Due to Faulty Occlusion Alarm
Asensus Surgical Inc. Recalls Senhance Surgical System Due to Malfunctions with Unintended Movement of the Robotically-Assisted Surgical Device
Fresenius Medical Care Recalls Sanxin Single Use Syringes for Leakages
Baxter Healthcare Corporation Recalls Novum IQ Syringe Pump for Potential Underdosing
Cardinal Health Recalls Monoject Disposable Syringes for Incompatibilities with Syringe Pumps
Covidien LLC Recalls McGRATH MAC Video Laryngoscope Due to Stolen Defective Products
Teleflex, and Arrow International, Recall Pressure Injectable Catheter Kits for Mislabeling
Olympus Recalls Olympus High Flow Insufflation Unit Due to Over-Inflation
Fresenius Medical Care Recalls Some Hemodialysis Machines for Potential Exposure to Toxic Compounds
Philips Respironics Recalls V60 and V60 Plus Ventilators due to Power Management Printed Circuit Board Assemblies (PM PCBAs) Not Meeting Ventilator Standards
Hamilton Medical Inc. Recalls HAMILTON-C1, T1, MR-1 Ventilators for Capacitator Leaks and Short Circuits
Medline Industries Recalls Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution Due to Being Non-Sterile
Abbott Medical Recalls Proclaim and Infinity IPGs for Inability to Exit Magnetic Resonance Imaging (MRI) Mode
Mallinckrodt Manufacturing, LLC Recalls One-Way Valve, 22F x 22M for Not Opening Properly

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