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 16781–16800 of 38,428 recalls
Recalled Item: Blood Glucose Monitoring System
The Issue: power issues with the Accu-Chek¿ Guide Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blood Glucose Monitoring System
The Issue: power issues with the Accu-Chek¿ Guide Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blood Glucose Monitoring System
The Issue: power issues with the Accu-Chek¿ Guide Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blood Glucose Monitoring System
The Issue: power issues with the Accu-Chek¿ Guide Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blood Glucose Monitoring System
The Issue: power issues with the Accu-Chek¿ Guide Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EQ-400-RH-QZ and EQ-400-LH-BK products Product Usage: The device is a
The Issue: On September 27, 2019 Energetiq Technology (the manufacturer)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARESCAPE Respiratory Module E-sCAiOV
The Issue: Displayed End Tidal Oxygen (EtO2) and Fraction of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Airway Gas Option N-CAiO
The Issue: Displayed End Tidal Oxygen (EtO2) and Fraction of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARESCAPE Respiratory Module E-sCAiO
The Issue: Displayed End Tidal Oxygen (EtO2) and Fraction of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARESCAPE Respiratory Module E-sCAiOVE
The Issue: Displayed End Tidal Oxygen (EtO2) and Fraction of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARESCAPE Respiratory Module E-sCAiOE
The Issue: Displayed End Tidal Oxygen (EtO2) and Fraction of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARESCAPE Respiratory Module E-sCO
The Issue: Displayed End Tidal Oxygen (EtO2) and Fraction of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARESCAPE Respiratory Module E-sCOVX
The Issue: Displayed End Tidal Oxygen (EtO2) and Fraction of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TLC-2000 Therapeutic Medical Laser System Power Pack
The Issue: Power Pack (component) was shipped with an internal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TLC-2000 Therapeutic Medical Laser System
The Issue: 905 nm laser diodes may be below rated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TLC-2000 Therapeutic Medical Laser System
The Issue: 660 nm laser diodes may be below rated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for
The Issue: Power supply (Model Number: TLC-2003) ME90A2403F01 (24 VDC,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TLC-2000 Therapeutic Medical Laser System
The Issue: Laser Probe (Model Number: TLC-2001) Electromagnetic Interference (
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TLC-2000 Therapeutic Medical Laser System
The Issue: Device was shipped without a Unique Device Identification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TLC-2000 Therapeutic Medical Laser System
The Issue: Device was shipped without a Unique Device Identification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.