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 32941–32960 of 38,428 recalls
Recalled Item: RUSCH
The Issue: Although the Natural Rubber Latex caution symbol is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: loss of airway gas measurement in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOSAIQ
The Issue: When using CMA, if the user hovers the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE OEC Brivo 865 plus
The Issue: Laser aimer assemblies were shipped without certification of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens RAPIDComm¿ Data Management System. The RAPIDComm¿ Data Management System
The Issue: RAPIDComm¿ 5.0 Screen Layout will display incorrect test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker 5.0mm Acorn Bur Sterile Product Usage: The devices are
The Issue: There may be missing notches, partial notches or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker 2.0mm Tapered Round Elite Bur Sterile Product Usage: The
The Issue: There may be missing notches, partial notches or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker 3.0mm x 3.8mm Precision Neuro Drill Sterile Product Usage:
The Issue: There may be missing notches, partial notches or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker 5.0mm Round Fluted Bur Aggressive Sterile Product Usage: The
The Issue: There may be missing notches, partial notches or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker 1.5mm Wire Pass Drill Sterile Product Usage: The devices
The Issue: There may be missing notches, partial notches or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker 3.0mm x 3.8mm Neuro Drill Sterile Product Usage: The
The Issue: There may be missing notches, partial notches or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The
The Issue: There may be missing notches, partial notches or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker 4.0mm Round Fluted Bur Sterile Product Usage: The devices
The Issue: There may be missing notches, partial notches or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker 6.0mm Egg Bur Sterile Product Usage: The devices are
The Issue: There may be missing notches, partial notches or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker 5.5mm Round Fluted Bur Soft Touch Sterile Product Usage:
The Issue: There may be missing notches, partial notches or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue MX40 Wearable Patient Monitor in use with the Philips
The Issue: IntelliVue MX40 (part numbers 865350, 865352) with software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker 1.0mm Round Fluted Bur Sterile Product Usage: The devices
The Issue: There may be missing notches, partial notches or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch Sterile Product
The Issue: There may be missing notches, partial notches or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker 3.5mm Zyphr Elite Round Fluted Bur Sterile Product Usage:
The Issue: There may be missing notches, partial notches or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker 6.0mm Round Fluted Bur Aggressive Sterile Product Usage: The
The Issue: There may be missing notches, partial notches or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.