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 17321–17340 of 38,428 recalls
Recalled Item: VITROS 4600 Chemistry System
The Issue: Unsuccessful Calibration Due to Software Anomaly in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 250 Chemistry System
The Issue: Unsuccessful Calibration Due to Software Anomaly in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 250 Chemistry System
The Issue: Unsuccessful Calibration Due to Software Anomaly in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5
The Issue: Unsuccessful Calibration Due to Software Anomaly in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products Calibrator Kit 32
The Issue: Unsuccessful Calibration Due to Software Anomaly in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 250AT Chemistry System
The Issue: Unsuccessful Calibration Due to Software Anomaly in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 4600 Chemistry System
The Issue: Unsuccessful Calibration Due to Software Anomaly in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 350 Chemistry System
The Issue: Unsuccessful Calibration Due to Software Anomaly in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5600 Integrated System
The Issue: Unsuccessful Calibration Due to Software Anomaly in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products Calibrator Kit 32
The Issue: Unsuccessful Calibration Due to Software Anomaly in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CapsoCam Plus *** System
The Issue: mis-labeling of the device with incorrect serial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The
The Issue: Perfusion tubing pack was packaged with the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PediaLift Access Device
The Issue: The firm was unsuccessful in obtaining a satisfactory
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DEMO No Needle Corrugated Carton 20 U/D
The Issue: There is a potential for "No Needle Demo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DEMO No Needle Corrugated Carton 30 U/D
The Issue: There is a potential for "No Needle Demo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DEMO No Needle Corrugated Carton 40 U/D
The Issue: There is a potential for "No Needle Demo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DEMO No Needle Corrugated Carton 20 U/D
The Issue: There is a potential for "No Needle Demo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DEMO No Needle Corrugated Carton 30 U/D
The Issue: There is a potential for "No Needle Demo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic...
The Issue: Error in the default configuration which could lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition AS
The Issue: for four safety-related software issues impacting systems
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.