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 9361–9380 of 38,428 recalls
Recalled Item: DeRoyal CANNULTED HIP PACK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal TRANS CANAL PACK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VADER Pedicle System Torque Wrench
The Issue: During internal testing (at manufacturer site) of two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal FACIAL PACK PGYBK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal MYELOGRAM PACK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal LUMBAR/CERVICAL PACK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal SHOULDER KIT
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal VIT RD PACK 86ST
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 PAIN TRAY
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal CATARACT PACK CSM
The Issue: DeRoyal procedure packs that contain the affected 3M
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal KIT HEART B PACK
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART
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 MINOR ORAL / ENT PACK
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 PLASTIC HAND PACK RF
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEO-MED OPTHALMOLOGY CSTM PCK
The Issue: DeRoyal procedure packs that contain the affected 3M
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal LAPAROSCOPIC ROBOTIC TRAY
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEO-MED TOTAL KNEE PACK A & B PGYK
The Issue: DeRoyal procedure packs that contain the affected 3M
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal MYELOGRAM PACK
The Issue: DeRoyal procedure packs that contain the affected 3M
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.