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 9941–9960 of 38,428 recalls
Recalled Item: Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
The Issue: As a result of returned product complaints for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FULL VISION INC. TRACKMASTER
The Issue: This has been identified a rare occurrence, under
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FULL VISION INC. TRACKMASTER
The Issue: This has been identified a rare occurrence, under
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FULL VISION INC. TRACKMASTER
The Issue: This has been identified a rare occurrence, under
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FULL VISION INC. TRACKMASTER
The Issue: This has been identified a rare occurrence, under
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FULL VISION INC. TRACKMASTER
The Issue: This has been identified a rare occurrence, under
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FULL VISION INC. TRACKMASTER
The Issue: This has been identified a rare occurrence, under
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FULL VISION INC. TRACKMASTER
The Issue: This has been identified a rare occurrence, under
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MICRO-X ROVER MOBILE X-RAY SYSTEM
The Issue: Software calibration error with product equip with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The product is a handheld ultraviolet-C germicidal wand and contains
The Issue: Excessive ultraviolet-C radiation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: N Antiserum to Human IgG
The Issue: N Antiserum to Human IgG are not meeting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: N Antiserum to Human IgG
The Issue: N Antiserum to Human IgG are not meeting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
The Issue: Drill Pin (drill bit) is not compatible with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pinnacle3 Radiation Therapy Planning System
The Issue: When computing a radiation dose in the system,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Iso-Gard Filter S
The Issue: Incidents of device splitting or detaching during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Iso-Gard Filter S
The Issue: Incidents of device splitting or detaching during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Iso-Gard Filter S
The Issue: Incidents of device splitting or detaching during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Filter + Catheter Mount
The Issue: Incidents of device splitting or detaching during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intersurgical Solus Standard
The Issue: Printing error on the device, size 3 Solus
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Iso-Gard Filter S
The Issue: Incidents of device splitting or detaching during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.