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 13681–13700 of 38,428 recalls
Recalled Item: DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual
The Issue: RIA 2 reamer head breakage exceeds the expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual
The Issue: RIA 2 reamer head breakage exceeds the expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic
The Issue: RIA 2 reamer head breakage exceeds the expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual
The Issue: RIA 2 reamer head breakage exceeds the expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept
The Issue: A software anomaly in the A620 Patient Programmer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual
The Issue: RIA 2 reamer head breakage exceeds the expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual
The Issue: RIA 2 reamer head breakage exceeds the expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic
The Issue: RIA 2 reamer head breakage exceeds the expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual
The Issue: RIA 2 reamer head breakage exceeds the expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual
The Issue: RIA 2 reamer head breakage exceeds the expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual
The Issue: RIA 2 reamer head breakage exceeds the expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2
The Issue: RIA 2 reamer head breakage exceeds the expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual
The Issue: RIA 2 reamer head breakage exceeds the expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual
The Issue: RIA 2 reamer head breakage exceeds the expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual
The Issue: RIA 2 reamer head breakage exceeds the expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual
The Issue: RIA 2 reamer head breakage exceeds the expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ENNOVATE MIS REMOVALKEY SHORT
The Issue: Fracture or breakage of the spinal fixation arm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optilite Freelite Mx Kappa Free Kit .M.OPT.A
The Issue: Due to customer complaints of positive bias impacting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IcePearl" 2.1 CX 90¿ Cryoablation Needle
The Issue: Complaint trend regarding needle shaft gas leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IceSeed" 1.5 Cryoablation Needle
The Issue: Complaint trend regarding needle shaft gas leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.