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.

38,428 total recalls
0 this month

Showing 18701–18720 of 38,428 recalls

March 8, 2019· Gyrus ACMI, Inc.

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.

Class II — Potential Health HazardTerminated
March 8, 2019· Integra LifeSciences Corp.

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.

Class II — Potential Health HazardTerminated
March 8, 2019· Integra LifeSciences Corp.

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.

Class II — Potential Health HazardTerminated
March 8, 2019· Integra LifeSciences Corp.

Recalled Item: Salto Talaris Tibial Ankle Prosthesis Tray

The Issue: The Salto Talaris and Integra XT Revision implant

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
March 8, 2019· Integra LifeSciences Corp.

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.

Class II — Potential Health HazardTerminated
March 8, 2019· Gyrus ACMI, Inc.

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.

Class II — Potential Health HazardTerminated
March 8, 2019· Integra LifeSciences Corp.

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.

Class II — Potential Health HazardTerminated
March 8, 2019· Integra LifeSciences Corp.

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.

Class II — Potential Health HazardTerminated
March 8, 2019· Integra LifeSciences Corp.

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.

Class II — Potential Health HazardTerminated
March 8, 2019· Integra LifeSciences Corp.

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.

Class II — Potential Health HazardTerminated
March 8, 2019· Gyrus ACMI, Inc.

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.

Class II — Potential Health HazardTerminated
March 8, 2019· Integra LifeSciences Corp.

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.

Class II — Potential Health HazardTerminated
March 8, 2019· Integra LifeSciences Corp.

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.

Class II — Potential Health HazardTerminated
March 8, 2019· Integra LifeSciences Corp.

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.

Class II — Potential Health HazardTerminated
March 8, 2019· Gyrus ACMI, Inc.

Recalled Item: Diego Elite Blades Monopolar

The Issue: Olympus Diego Elite Consoles may inadvertently permit activation

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
March 8, 2019· Integra LifeSciences Corp.

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.

Class II — Potential Health HazardTerminated
March 8, 2019· Integra LifeSciences Corp.

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.

Class II — Potential Health HazardTerminated
March 8, 2019· Integra LifeSciences Corp.

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.

Class II — Potential Health HazardTerminated
March 8, 2019· Integra LifeSciences Corp.

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.

Class II — Potential Health HazardTerminated
March 8, 2019· Integra LifeSciences Corp.

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.

Class II — Potential Health HazardTerminated