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 17481–17500 of 38,428 recalls
Recalled Item: Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary
The Issue: Incomplete packaging seal of sterile product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Co-Flex NL 4" - Product Usage: Single Use secondary
The Issue: Incomplete packaging seal of sterile product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iGUIDE System with software build iGuide 2.2.0
The Issue: for iGUIDE to incorrectly monitor the 3D
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ElectroMist product codes: 36-3310-25 - Product Usage: Electrode...
The Issue: for failed stability antimicrobial effectiveness testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alpha Conducting solution product codes: 3310-25 ASCR - Product Usage:
The Issue: for failed stability antimicrobial effectiveness testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ElectroMist product codes: 36-3310-60 - Product Usage: Electrode...
The Issue: for failed stability antimicrobial effectiveness testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ElectroMist product codes: 36-3310-04 - Product Usage: Electrode...
The Issue: for failed stability antimicrobial effectiveness testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrode
The Issue: for failed stability antimicrobial effectiveness testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dual-Sided Interhemispheric
The Issue: Supplemental information provided with devices indicates that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Depth Electrodes
The Issue: Supplemental information provided with devices indicates that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Skull Anchor Bolts
The Issue: Supplemental information provided with devices may indicate that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LSB Style Anchor Bolt. Labeled with the following parts: 13mm
The Issue: On June 12, 2019 Ad-Tech was made aware
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato
The Issue: Discrepant length; Lot B88751 90mm screws were manufactured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Versa - Kath Mini Kit
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Versa - Kath Mini Kit
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEEP Precision Integrated System 120V & LEEP Precision Generator
The Issue: The products' cut, coagulate, or blend function may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal THE RESOURCE GROUP
The Issue: Custom surgical packs are being recalled because it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Surgical System
The Issue: One da Vinci Xi Endoscope Controller in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS...
The Issue: Potentially Biased Results using VITROS Chemistry Products GLU
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CS100 Intra-Aortic Balloon Pump
The Issue: If battery maintenance is not performed appropriately, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.