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 23761–23780 of 38,428 recalls
Recalled Item: Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit
The Issue: An incomplete seal at the chevron end of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Glidesheath Slender Hydrophilic Coated Introducer Sheath
The Issue: An incomplete seal at the chevron end of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit
The Issue: An incomplete seal at the chevron end of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Glidesheath Slender Hydrophilic Coated Introducer Sheath
The Issue: An incomplete seal at the chevron end of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Glidesheath Slender Hydrophilic Coated Introducer Sheath
The Issue: An incomplete seal at the chevron end of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Glidesheath Slender Hydrophilic Coated Introducer Sheath
The Issue: An incomplete seal at the chevron end of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Glidesheath Slender Hydrophilic Coated Introducer Sheath
The Issue: An incomplete seal at the chevron end of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Glidesheath Slender Hydrophilic Coated Introducer Sheath
The Issue: An incomplete seal at the chevron end of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ThermaSure(TM)
The Issue: Dryer unit not heating. Manufacturing issue causes the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ThermaSure(TM)
The Issue: Dryer unit not heating. Manufacturing issue causes the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ThermaSure(TM)
The Issue: Dryer unit not heating. Manufacturing issue causes the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAKO RIO Standard System
The Issue: An intermittent electrical problem that could lead to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP
The Issue: Medtronic has become aware that the VCLAS 15MM
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal(R) Dolphin Inflation Device
The Issue: Lack of sterility assurance. There is a defect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial
The Issue: Real-time shelf life testing failed at 24 months
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Helix Elite" Molecular Standards: Inactivated Standard. Inactivated...
The Issue: Real-time shelf life testing failed at 24 months
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Helix Elite" Molecular Standards: Inactivated Standard. Inactivated...
The Issue: Real-time shelf life testing failed at 24 months
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and
The Issue: Real-time shelf life testing failed at 24 months
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Helix Elite" Molecular Standards: Inactivated Standard. Inactivated...
The Issue: Real-time shelf life testing failed at 24 months
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Axiom Artis
The Issue: for liquid entry
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.