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 9821–9840 of 38,428 recalls
Recalled Item: MEDLINE LITHOTOMY
The Issue: Medline received complaints on some of the breather
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BAUSCH + LOMB PHACO PACK
The Issue: Medline received complaints on some of the breather
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BAUSCH + LOMB EYE PACK
The Issue: Medline received complaints on some of the breather
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BAUSCH + LOMB CATARACT PACK
The Issue: Medline received complaints on some of the breather
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System
The Issue: Radio frequency emission from a functioning WatchCare device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE LINQ TRAY
The Issue: Medline received complaints on some of the breather
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BAUSCH + LOMB CATARACT PACK
The Issue: Medline received complaints on some of the breather
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BAUSCH + LOMB EYE MUSCLE
The Issue: Medline received complaints on some of the breather
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hillrom Hospital Bed Accessory
The Issue: Radio frequency emission from a functioning WatchCare device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hillrom Hospital Bed Accessory
The Issue: Radio frequency emission from a functioning WatchCare device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker INBONE Tibial Tray
The Issue: The tibial tray lock detail is oversized (larger
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker INBONE Tibial Tray
The Issue: The tibial tray lock detail is oversized (larger
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Canon Aplio ultrasound system
The Issue: After completion, ultrasound system's Stress Echo may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: biokitHSV-2 Rapid Test
The Issue: HSV-2 rapid test may report false positive results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pilling Wecksorb Cylindrical Sponges
The Issue: Specific lots have not been irradiated to eliminate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-ASSAY IgA Immunoturbidimetric Assay
The Issue: IgA Reagent may start showing cloudiness over time,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo Stitch V-Loc 180 Absorbable Reload
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo Stitch V-Loc PBT Non-Absorbable Reload
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health GEL PACK REUSABLE
The Issue: Users are being informed that the product should
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health INSULATED GEL PACK REUSABLE
The Issue: Users are being informed that the product should
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.