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 6081–6100 of 38,428 recalls
Recalled Item: SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
The Issue: A non-compliant power cord may have been supplied
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
The Issue: A non-compliant power cord may have been supplied
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shimadzu
The Issue: Due to capacitor manufacturing issue, their is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Embrace Drill Tower
The Issue: The surgical techniques for the Embrace Shoulder Instruments
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MRI system: Vantage Elan
The Issue: For some MRI systems, it has been found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vantage Titan
The Issue: For some MRI systems, it has been found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Embrace Drill Tower
The Issue: The surgical techniques for the Embrace Shoulder Instruments
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MRI system: Vantage Orian
The Issue: For some MRI systems, it has been found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage Cartridge Express with Speedswap
The Issue: Product is recalled due to reports of blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm
The Issue: This Field Action is being conducted following the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm
The Issue: This Field Action is being conducted following the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915
The Issue: A software defect affecting VITROS Systems running VITROS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS XT 7600 Integrated System
The Issue: A software defect affecting VITROS Systems running VITROS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS XT 3400 Chemistry System
The Issue: A software defect affecting VITROS Systems running VITROS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS XT 7600 Integrated System
The Issue: A software defect affecting VITROS Systems running VITROS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914
The Issue: A software defect affecting VITROS Systems running VITROS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440
The Issue: A software defect affecting VITROS Systems running VITROS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915
The Issue: A software defect affecting VITROS Systems running VITROS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440
The Issue: A software defect affecting VITROS Systems running VITROS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914
The Issue: A software defect affecting VITROS Systems running VITROS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.