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Medical Device Safety

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
Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure: FDA Safety Communication
BioZorb Markers and Potential Risks with Use in Breast Tissue: FDA Safety Communication
Do Not Use Smartwatches or Smart Rings to Measure Blood Glucose Levels: FDA Safety Communication
Do Not Use Certain Cardinal Health Monoject Luer-Lock and Enteral Syringes – FDA Safety Communication
Certain ResMed Ltd Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety Communication
Risks with Exactech Equinoxe Shoulder System with Defective Packaging - FDA Safety Communication
2024 Safety Communications
Do Not Use Synovo Total Hip Resurfacing System: FDA Safety Communication
Retiro del mercado voluntario de los equipos SoClean para uso con dispositivos y accesorios de CPAP: Comunicado de seguridad de la FDA
Vigile cuidadosamente las máquinas CPAP Philips DreamStation 2 por si se presentan signos de sobrecalentamiento: Comunicado de seguridad de la Administración de Alimentos y Medicamentos s
Evaluación de jeringuillas de plástico fabricadas en China para detectar posibles fallos de los dispositivos: Comunicado de seguridad de la FDA
No utilice determinadas marcas de productos médicos de suero salino y agua estéril de Nurse Assist porque pueden no ser estériles: Comunicado de seguridad de la FDA

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
Follow Instructions for Safe Use of Electrical Operating Room Tables - Letter to Health Care Providers
2024 Letters to Health Care Providers
Potential Exposure to Certain Chemicals with Use of GE HealthCare EVair and EVair03 Compressors with Certain Ventilators - Letter to Health Care Providers
HSV-2 Tests for Genital Herpes Can Produce False Reactive Results - Letter to Clinical Laboratory Staff and Health Care Providers

MORE LETTERS TO HEALTH CARE PROVIDERS

Recent Medical Device Recalls

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

Device Name Publish Date
Datex-Ohmeda Recalls EVair Air Compressors Due to Formaldehyde Emissions Found in Specific Conditions When Used with CARESCAPE R860, Engstrom Carestation or Pro Ventilators
Wipro GE Healthcare Private Ltd. Recalls Care Plus, Care Plus models 1000-4000 and Lullaby Incubators Due to Problems with Door Latch
Olympus Corporation of the Americas Recalls Laser-Compatible Olympus Bronchoscopes for Risk of Endobronchial Combustion and Patient Burns
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

MORE MEDICAL DEVICE RECALLS

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