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 13861–13880 of 38,428 recalls
Recalled Item: MassChrom Amino Acid Analysis Plasma Control Level II
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model
The Issue: for a false-negative result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model
The Issue: for a false-negative result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
The Issue: for a false-negative result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number:
The Issue: for a false-negative result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2)
The Issue: for a false-negative result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number:
The Issue: for a false-negative result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage:
The Issue: Ventilator may experience potential issues with the backup
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage:
The Issue: Ventilator may experience potential issues with the backup
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage:
The Issue: Ventilator may experience potential issues with the backup
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage:
The Issue: Ventilator may experience potential issues with the backup
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage:
The Issue: Ventilator may experience potential issues with the backup
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage:
The Issue: Ventilator may experience potential issues with the backup
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left)
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product
The Issue: Ventilator may experience potential issues with the backup
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage:
The Issue: Ventilator may experience potential issues with the backup
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage:
The Issue: Ventilator may experience potential issues with the backup
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage:
The Issue: Ventilator may experience potential issues with the backup
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage:
The Issue: Ventilator may experience potential issues with the backup
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics V680 Ventilator Part Number 850011 - Product Usage:
The Issue: Ventilator may experience potential issues with the backup
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.