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 22441–22460 of 38,428 recalls
Recalled Item: Innova Self-Expanding Stent System
The Issue: Stent possibly unable to be fully released from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Innova Self-Expanding Stent System
The Issue: Stent possibly unable to be fully released from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Unifine Pentips 5mm x 31G pen needles
The Issue: Device may potentially be compromised by water in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Unifine Pentips 5mm x 31G pen needles
The Issue: Device may potentially be compromised by water in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access 2 Immunoassay System
The Issue: for minor skin burn if the tool
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxC 600i SYNCHRON Access Clinical Systems
The Issue: for minor skin burn if the tool
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access 2 Immunoassay System
The Issue: for minor skin burn if the tool
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Handicare C Series Patient Lift Product Usage: A device used
The Issue: Premature strap wear and breakage at maximum weight
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Handicare P600 Series Patient Lift Product Usage: A device used
The Issue: Premature strap wear and breakage at maximum weight
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: First Step Flexible Endoscope Bedside Pre-Clean Kit
The Issue: Affected lots may have exceeded its microbial limits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NovaKone Toric Daily Wear Soft contact
The Issue: Contact lenses lack sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxH800
The Issue: The shield for the Single-Tube Station on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alden Classic 38 Sphere Daily Wear Soft contact
The Issue: Contact lenses lack sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NovaKone Daily Wear Soft contact
The Issue: Contact lenses lack sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alden HP59 Toric Daily Wear Soft contact
The Issue: Contact lenses lack sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alden HP49 Toric Daily Wear Soft contact
The Issue: Contact lenses lack sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxH600
The Issue: The shield for the Single-Tube Station on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alden HP49 Sphere Daily Wear Soft contact
The Issue: Contact lenses lack sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alden Classic 55 Toric Daily Wear Soft contact
The Issue: Contact lenses lack sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alden HP54 Toric Daily Wear Soft contact
The Issue: Contact lenses lack sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.