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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
Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results: FDA Safety Communication
FDA 鼓励公众遵守既定的噎食抢救协议：FDA 安全通报
Hinihikayat ng FDA ang Publiko na Sundin ang mga Protocol sa Pagsagip sa Nabubulunan: Komunikasyong Pangkaligtasan ng FDA
请勿使用 Synovo 全髋关节表面置换系统：美国食品药品管理局 (FDA) 安全通报
Huwag Gamitin ang Synovo Total Hip Resurfacing System: Komunikasyong Pangkaligtasan ng FDA
No utilice el sistema de revestimiento total de cadera de Synovo: 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
Disruptions in Availability of BD BACTEC Blood Culture Media Bottles - Letter to Health Care Providers
Do Not Use Medtronic NIM Standard and Contact EMG Endotracheal Tubes - Letter to Health Care Providers
Safety and Quality Concerns with Getinge Cardiovascular Devices - Letter to 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
Eye Injection Kit Recall: Bausch + Lomb/Synergetics Inc. Removes Certain I-Pack Injection Kits Due to Potential Non-Sterility
Ventilator Recall: Baxter Removes Life2000 Ventilator Due to Potential Failure of Battery Charging Dongle
Electrode Pad Correction: Megadyne Issues Correction for MEGA SOFT, MEGA SOFT DUAL and MEGA 2000 Patient Return Electrodes to Limit Risk of Pediatric Burns
Ventilator Software Correction: Hamilton Medical Issues Correction for HAMILTON-C6 Medical Ventilators to Address Risk of Failed Ventilation Restart
An Implantable Hypoglossal Nerve Stimulator Device Removal: Inspire Medical Systems, Inc. Removes Inspire IV Implantable Pulse Generator due to Manufacturing Defect That Can Result in System Malfunctions
Radiofrequency (RF) Coils Correction: Philips North America LLC Updates Use Instructions For SENSE XL Torso (1.5T And 3.0T) Coils Due to a Potential Issue Where the Coil Heats Up During MRI Scans, Possibly Leading to Thermal Injury
Continuous Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions for OmniLab Advanced+ (OLA+) Ventilator due to Interruptions and/or Loss of Therapy
Left Ventricular Assist System (LVAS) Monitor Correction: Abbott Medical Issues Correction for HeartMate LVAS System Monitor due to Screen Issues that May Cause Unintentional Pump Stop
Ventilator Correction: ZOLL Medical Corporation Updates Use Instructions For 731 Ventilators Due to Missing MRI Safety Information in The Labeling That May Lead to Misuse and Ventilator Failure
Continuous Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions for BiPAP V30, BiPAP A30, BiPAP A40 Due to Interruptions and/or Loss of Therapy
Electrode Pad Recall: Megadyne Removes MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes for Risk of Serious Burn Injuries to Patients
Getinge Recalls Vaporizer Sevoflurane Maquet Filling for Risk of Patient and Health Care Professional Exposure to Toxic Chemical Hydrogen Fluoride
Teleflex/Arrow International Recall Arrow FiberOptix and UltraFlex Intra-Aortic Balloon (IAB) Catheter Kits for Manufacturing Issue That May Prevent Full Balloon Inflation and Cause Patient Harm
Endotracheal Tube Recall: Medline Industries, LP Removes Medline Sub-G Endotracheal Tube with Subglottic Suctioning due to Detachment or Tearing of the Inflation Tube from the Main Tube
Medtronic Recalls StealthStation S8 Application Versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 for Software Error that May Cause Incorrect Measurements During Cranial Surgery
OptumHealth Care Solutions Recalls Nimbus II Infusion Pump Systems Under Recall by InfuTronix, LLC
Vyaire Medical, Inc. Recalls the Twin Tube Due to The Potential of The Nozzle Separating During Patient Use
Hologic, Inc. Recalls BioZorb Marker Due to Complications with Implanted Devices
Abbott Recalls HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kit for Risk of Blood Leakage or Air Entering System Between Inflow Cannula and Apical Cuff
Philips Respironics, Inc. Recalls Trilogy Evo Continuous Ventilators due to a Software-Related Possible Power Malfunction
Route 92 Medical Inc. Recalls Catheter due to Distal Tip Separation at the Proximal Marker Band
Tandem Diabetes Care, Inc. Recalls Version 2.7 of the Apple iOS t:connect Mobile App Used in Conjunction with t:slim X2 Insulin Pump with Control-IQ Technology Prompted by a Software Problem Leading to Pump Battery Depletion
BioMérieux Inc. Recalls VITEK 2 AST Kit due to Incorrect Ceftriaxone Concentrations
SonarMed Inc. Recalls Airway Monitors Due to a Software Anomaly Resulting in Failure to Detect a Partial Obstruction in 2.5mm Sensors and Up To 3mm Distal to the Sensor Tip
SonarMed Inc. Recalls Airway Acoustic Sensors Due to a Restricted Inner Diameter of Airway Causing Suction Catheter Passage Difficulty

MORE MEDICAL DEVICE RECALLS

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