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 14201–14220 of 38,428 recalls
Recalled Item: AESCULAP S4 Cervical Cross Connector L24mm
The Issue: Insufficient clamping force of the cross connectors in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AESCULAP S4 Cervical Cross Connector L 42-58mm
The Issue: Insufficient clamping force of the cross connectors in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AESCULAP S4 Cervical Cross Connector L 33-42mm
The Issue: Insufficient clamping force of the cross connectors in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AESCULAP S4 Cervical Cross Connector L 28-33mm
The Issue: Insufficient clamping force of the cross connectors in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AESCULAP S4 Cervical Cross Connector L22mm
The Issue: Insufficient clamping force of the cross connectors in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AESCULAP S4 Cervical Cross Connector
The Issue: Insufficient clamping force of the cross connectors in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: System
The Issue: electrical arc flash within the Power Gradient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tomographic Imager Combining Emission Computed Tomography With Nuclear...
The Issue: electrical arc flash within the Power Gradient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: System
The Issue: electrical arc flash within the Power Gradient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: System
The Issue: electrical arc flash within the Power Gradient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: System
The Issue: electrical arc flash within the Power Gradient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MediCult Vitrification Cooling Media
The Issue: There is a discrepancy between the printing on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AC/DC POWER SUPPLY for 7400
The Issue: The AC/DC adapter (power supply) of the portable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AC/DC POWER SUPPLY for 7400
The Issue: The AC/DC adapter (power supply) of the portable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neoprobe GDS Control Unit
The Issue: It was discovered during a documentation review that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B. Braun Introcan IV Safety Catheters
The Issue: Recalled products do not have FDA approval for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055
The Issue: Product not properly being aligned with the adequate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055
The Issue: Product not properly being aligned with the adequate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Regenerex Primary Taper Cap Item Number 141269
The Issue: Product not properly being aligned with the adequate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1500 Flex Heat and Moisture Exchanger
The Issue: Firm has received 6 complaints that the Heat
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.