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 18721–18740 of 38,428 recalls
Recalled Item: Diego Elite Turbinate Blades Bipolar Blade
The Issue: Olympus Diego Elite Consoles may inadvertently permit activation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Talar Dome Total Ankle Prosthesis
The Issue: The Salto Talaris and Integra XT Revision implant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Talar Dome Total Ankle Prosthesis
The Issue: The Salto Talaris and Integra XT Revision implant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Talar Dome Total Ankle Prosthesis
The Issue: The Salto Talaris and Integra XT Revision implant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diego Elite Turbinate Blades Bipolar Blade
The Issue: Olympus Diego Elite Consoles may inadvertently permit activation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tibial Total Ankle Prosthesis Tray
The Issue: The Salto Talaris and Integra XT Revision implant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diego Elite Turbinate Blades Bipolar Blade
The Issue: Olympus Diego Elite Consoles may inadvertently permit activation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Salto Talaris Tibial Total Ankle Prosthesis Tray
The Issue: The Salto Talaris and Integra XT Revision implant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Salto Talaris Tibial Total Ankle Prosthesis Tray
The Issue: The Salto Talaris and Integra XT Revision implant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diego Elite Malleable
The Issue: Olympus Diego Elite Consoles may inadvertently permit activation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tibial Total Ankle Prosthesis Tray
The Issue: The Salto Talaris and Integra XT Revision implant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Talar Dome Total Ankle Prosthesis
The Issue: The Salto Talaris and Integra XT Revision implant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diego Elite Turbinate Blades Bipolar Blade
The Issue: Olympus Diego Elite Consoles may inadvertently permit activation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tibial Total Ankle Prosthesis Tray
The Issue: The Salto Talaris and Integra XT Revision implant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Diego Elite Console MDCONS 100
The Issue: Olympus Diego Elite Consoles may inadvertently permit activation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Salto Talaris
The Issue: The Salto Talaris and Integra XT Revision implant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ULRICH Torque Limiting Handle for use with a Set Screw
The Issue: Certain Torque Limiting Handles in the field are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25
The Issue: BD PAS received customer complaints indicating the absence
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker High Flow II Tube Set
The Issue: The heated tube sets were consistently leaking and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP)
The Issue: The heated tube sets were consistently leaking and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.