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 28601–28620 of 38,428 recalls
Recalled Item: Perkin Elmer WIZARD2 5-detector
The Issue: The content of the second #023 barcode ID
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Perkin Elmer WIZARD2 10-detector
The Issue: The content of the second #023 barcode ID
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Perkin Elmer WIZARD2 2-detector
The Issue: The content of the second #023 barcode ID
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Perkin Elmer ClWIZARD2 5-detector
The Issue: The content of the second #023 barcode ID
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Oscillating Flat - TS ST Hub
The Issue: Two lots of oscillating saw blades incorrectly identify
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: Coil overheating can occur when the device is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Excella II Rod Cat. No.: SR 55100 5.5 x 100
The Issue: Innovasis recalled two lots of Excella II titanium
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAGNETOM systems
The Issue: installation error of the quench lines of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quick Connects. Steris Corporation. Model numbers: QKC1736E
The Issue: The firm discovered that one of the hysteroscope
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model NuCARTGN. The NuCART is a mobile display and image
The Issue: The attachment of the NuCART Spring Arm to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synaptive Medical BrightMatter Navigator System (Guide System). Part number...
The Issue: Out of tolerance for radio frequency emissions. At
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion
The Issue: There have been intermittent issues with Supercap POST
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAQUET Servo Humidifier 163
The Issue: Cracking may occur at the 15mm and 22mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Servo Humidifier 163
The Issue: Cracks may occur at the 15mm and 22mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Position Pro Mattress. Mattress
The Issue: for power cord to melt; hazards include
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VS200 radiographic Cassette Holder or Wall Stand. For use in
The Issue: The wall stand cassette holder can suddenly fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VS300 radiographic Cassette Holder or Wall Stand. For use in
The Issue: The wall stand cassette holder can suddenly fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGEN System Tibial Component Size Stemmed 3 Precoat
The Issue: A product complaint was received stating that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon
The Issue: Stability data does not substantiate the labeled two-year
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.