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 31181–31200 of 38,428 recalls
Recalled Item: N Latex IgM
The Issue: Complaints have been confirmed on failed proficiency testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TDX Electric Wheelchair. Invacare FDX
The Issue: If the slack in the wires is not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FDX Electric Wheelchair. Invacare FDX
The Issue: If the slack in the wires is not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Storm Series Electric Wheelchair. Invacare FDX
The Issue: If the slack in the wires is not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Si Surgical System
The Issue: The Wall chart has been updated because it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ikaria
The Issue: delivery failure alarm condition. INOmax DSIR with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQUAPAK 101 SW
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADAPTOR
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQUAPAK 640 SW
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQUAPAK 340 SW
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQUAPAK 340 SW
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQUA 540 SW
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQUAPAK SW/EAU STERILE
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQUAPAK 640 SW
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQUAPAK 340 SW
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hudson RCI¿ Humidifier Adaptor
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQUAPAK 640 SW
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQUAPAK 340 SW
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQUAPAK SW/EAU STERILE
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQUAPAK 640 SW
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.