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 11561–11580 of 38,428 recalls
Recalled Item: THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
The Issue: Product was released prior to all testing being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cliquid MD version 3.4 software used in conjunction with Analyst
The Issue: The values of the Internal Standard (IS) concentrations
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SMART FLEX 6x150 BIL
The Issue: There is a potential for distal tip dislodgement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SMART FLEX 10x100 BIL
The Issue: There is a potential for distal tip dislodgement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SMART FLEX 10x100 BIL
The Issue: There is a potential for distal tip dislodgement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OMNI K2 Hip Stem
The Issue: The device is missing grit blasting on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SMART FLEX 8x60 BIL
The Issue: There is a potential for distal tip dislodgement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SMART FLEX 9x60 BIL
The Issue: There is a potential for distal tip dislodgement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SMART FLEX 6x120 BIL
The Issue: There is a potential for distal tip dislodgement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ellume COVID-19 Home Test
The Issue: Due to a higher rate of false positive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: .15.020
The Issue: There is a potential that the length of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: .15.010
The Issue: There is a potential that the length of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MENTOR Saline-Filled Breast Implants are constructed from room temperature...
The Issue: Due to a manufacturing issue, Implant may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: API 50 CH
The Issue: There is potential to provide an incorrect organism
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT i1000SR /1L86 and 1L87
The Issue: Twelve software-related issues affecting software version 9.41 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT c4000 /2P24
The Issue: Twelve software-related issues affecting software version 9.41 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
The Issue: Coagulate function may not operate with the use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEEP PRECISION Integrated System
The Issue: Coagulate function may not operate with the use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
The Issue: Coagulate function may not operate with the use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.