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 9421–9440 of 38,428 recalls
Recalled Item: DeRoyal CATARACT PACK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal CNRV SPINAL PACK
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 BASIC NEURO PACK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal ACDF PACK PGYBK A PACK / B PACK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEO-MED CATARACT PACK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal SHOULDER ARTHOSCOPY PACK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal TLIF 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 BREAST AUGMENTATION PACK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal PODIATRY PACK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal LAMINECTOMY SPINAL FUSION PACK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal FOOT PACK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal NEURO SPINE BACK PACK PGYBK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal LAMINECTOMY SPINAL FUSION 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 HAND PACK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal EYE PACK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal PAIN TRAY
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal PICC LINE TRAY PGYBK
The Issue: DeRoyal procedure packs that contain the affected 3M
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEO-MED TOTAL KNEE PACK A & B
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.