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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 Medical Device Safety Communications

The FDA's analyses and recommendations for patients and health care providers about ongoing medical device safety issues.

Recent Medical Device Recalls

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

Device Name Publish Date
Philips Recalls BrightView Imaging Systems Due to the Detector Unexpectedly Falling
Smiths Medical ASD Inc. Recalls Medfusion Model 4000 Syringe Pump Due to Issues Associated with Earlier Software Versions
Percussionaire Recalls High Frequency Transport Phasitron Breathing Circuit Kits for Over-Pressurization
Maquet Cardiovascular, LLC Recalls Atrium Express Dry Suction Dry Seal Chest Drain Containing Sterile Water Based Products Under Recall by Nurse Assist
Globus Medical, Inc. Recalls ExcelsiusGPS Flat Panel Fluoroscopy Registration Fixture Due to a Calibration Error
ROi CPS, LLC Recalls Regard Operative Lap P&S Surgical Kit Due to Possible Lack of Sterility
Fresenius Kabi USA, LLC Recalls Ivenix Large Volume Pump (LVP) of the Ivenix Infusion System Due to Mechanical Interference
ResMed Ltd. Recalls Continuous Positive Airway Pressure (CPAP) Masks with Magnets due to Possible Magnetic Interference with Certain Medical Devices
Busse Hospital Disposables, Inc. Recalls Care Trays and Kits Containing Sterile Water Based Products Under Recall by Nurse Assist
Megadyne Medical Products, Inc. Recalls Mega Soft Universal Patient Return Electrode Due to Reports of Patient Burns
2024 Medical Device Recalls
Insulet Corporation Recalls Omnipod 5 Android App due to a Software Error
Philips North America LLC Recalls Panorama 1.0T HFO due to a Risk of Explosion During a Quench Procedure Caused by Excessive Pressure Buildup of Helium Gas
Olympus Corporation of the Americas Recalls Bronchofiberscopes and Bronchovideoscopes Because They Can Lead to Burns and Fire
Medtronic Navigation Inc. Recalls StealthStation S8 Application Version 2.0 and 2.0.1 Due to a Software Glitch
Getinge Recalls CARDIOHELP Emergency Drive due to an Impaired or Inability to Turn the Drive
Cordis US Corp Recalls INFINITI Angiographic Catheter due to Products Being Shipped Without Undergoing Sterilization Procedures
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

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