Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 13881–13900 of 38,428 recalls
Recalled Item: Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product
The Issue: Ventilator may experience potential issues with the backup
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage:
The Issue: Ventilator may experience potential issues with the backup
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage:
The Issue: Ventilator may experience potential issues with the backup
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage:
The Issue: Ventilator may experience potential issues with the backup
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage:
The Issue: Ventilator may experience potential issues with the backup
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory
The Issue: Breakdown of the sound abatement washer, and metal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PryTime Medical - ER-Reboa Plus Catheter
The Issue: There is a potential that catheters may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva
The Issue: Calibrator lots may not meet stability criteria and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MassChrom Cortisol
The Issue: Control lots may not meet stability criteria and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MassChrom Cortisol
The Issue: Control lots may not meet stability criteria and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G
The Issue: The manufacturer has determined that with certain uncommon
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAC VU360
The Issue: Incorrect patient identification and/or patient demographic errors
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MANI Infusion Cannula 23G S - Product Usage: for use
The Issue: Dimensions of the Luer connector parts out of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MANI TROCAR KIT 23G S - Product Usage: for use
The Issue: Dimensions of the Luer connector parts out of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM 1300 Analyzer - Product Usage: automated
The Issue: Test Definition scanning may reset custom settings to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM 1600 Analyzer - Product Usage: automated
The Issue: Test Definition scanning may reset custom settings to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VGlove NITRILE *** Protect Your Life 100 Patient examination gloves
The Issue: Package labeled as nitrile gloves, contains latex gloves
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Viral Transport Medium
The Issue: There is a potential for contamination within Viral
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23
The Issue: for Transcatheter Aortic Valve (TAV) leaflet damage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Evolut (TM) PRO+ System. With the following model numbers: a.
The Issue: for Transcatheter Aortic Valve (TAV) leaflet damage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.