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 81–100 of 38,428 recalls
Recalled Item: PIE Trolley System Model: 2005
The Issue: Lack of 510K clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PIE PAK Models: P2HC-A
The Issue: Lack of 510K clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Octopus Nuvo Tissue Stabilizer
The Issue: During the manufacturing, Medtronic personnel identified an assembly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number:
The Issue: Pumps were released without full testing being performed,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4
The Issue: units manufactured in a limited time period may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo-Model Replacement Plateau
The Issue: The potential for an implant with a plateau
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo-Model Replacement Plateau
The Issue: The potential for an implant with a plateau
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo-Model SL Connection Component incl. PE-Plateau
The Issue: The potential for an implant with a plateau
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo-Model Replacement Plateau
The Issue: The potential for an implant with a plateau
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo-Model Replacement Plateau
The Issue: The potential for an implant with a plateau
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo-Model Replacement Plateau
The Issue: The potential for an implant with a plateau
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo-Model SL Connection Component incl. PE-Plateau
The Issue: The potential for an implant with a plateau
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo-Model Replacement Plateau
The Issue: The potential for an implant with a plateau
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo-Model SL Connection Component incl. PE-Plateau
The Issue: The potential for an implant with a plateau
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo-Model Replacement Plateau
The Issue: The potential for an implant with a plateau
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo-Model Replacement Plateau
The Issue: The potential for an implant with a plateau
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo-Model Replacement Plateau
The Issue: The potential for an implant with a plateau
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo-Model Replacement Plateau
The Issue: The potential for an implant with a plateau
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: APTUS Product Name: 2.5 TriLock Screw 16mm
The Issue: Mix up between specified lots of 2.5mm and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: APTUS Product Name: 2.8 TriLock Screw 16mm
The Issue: Mix up between specified lots of 2.5mm and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.