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 9481–9500 of 38,428 recalls
Recalled Item: DeRoyal TOTAL SHOULDER PACK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal BASIC EYE PACK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal NEURO PACK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal SPINAL FUSION PACK
The Issue: DeRoyal procedure packs that contain the affected 3M
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal TOTAL HIP KIT
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal HEART PACK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal SHOULDER PACK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal ENDOVENOUS PACK
The Issue: DeRoyal procedure packs that contain the affected 3M
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal CUSTOM NEURO PACK
The Issue: DeRoyal procedure packs that contain the affected 3M
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal BIOPSY PACK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal BASIC NEURO PACK
The Issue: DeRoyal procedure packs that contain the affected 3M
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal EYE PACK
The Issue: DeRoyal procedure packs that contain the affected 3M
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal CATARACT PACK
The Issue: DeRoyal procedure packs that contain the affected 3M
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal LAPINECTOMY PACK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEO-MED PODIATRY PACK PGYBK
The Issue: DeRoyal procedure packs that contain the affected 3M
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal NEURO PACK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal CRANI PACK
The Issue: DeRoyal procedure packs that contain the affected 3M
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total...
The Issue: Due to tears reported tears in the cannula
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HENRY SCHEIN
The Issue: Medical and surgical procedure trays and kits underwent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STRADIS HEALTHCARE
The Issue: Medical and surgical procedure trays and kits underwent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.