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 25321–25340 of 38,428 recalls

January 9, 2017· Resource Optimization & Innovation Llc

Recalled Item: Regard

The Issue: Custom procedure trays contain a component, a light

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

Class II — Potential Health HazardTerminated
January 9, 2017· Resource Optimization & Innovation Llc

Recalled Item: Regard

The Issue: Custom procedure trays contain a component, a light

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

Class II — Potential Health HazardTerminated
January 9, 2017· Resource Optimization & Innovation Llc

Recalled Item: Regard

The Issue: Custom procedure trays contain a component, a light

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

Class II — Potential Health HazardTerminated
January 9, 2017· Resource Optimization & Innovation Llc

Recalled Item: Regard

The Issue: Custom procedure trays contain a component, a light

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

Class II — Potential Health HazardTerminated
January 9, 2017· Resource Optimization & Innovation Llc

Recalled Item: Regard

The Issue: Custom procedure trays contain a component, a light

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

Class II — Potential Health HazardTerminated
January 9, 2017· Resource Optimization & Innovation Llc

Recalled Item: Regard

The Issue: Custom procedure trays contain a component, a light

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

Class II — Potential Health HazardTerminated
January 9, 2017· Resource Optimization & Innovation Llc

Recalled Item: Regard

The Issue: Custom procedure trays contain a component, a light

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

Class II — Potential Health HazardTerminated
January 9, 2017· Resource Optimization & Innovation Llc

Recalled Item: Regard

The Issue: Custom procedure trays contain a component, a light

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

Class II — Potential Health HazardTerminated
January 9, 2017· Resource Optimization & Innovation Llc

Recalled Item: Regard

The Issue: Custom procedure trays contain a component, a light

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

Class II — Potential Health HazardTerminated
January 9, 2017· Resource Optimization & Innovation Llc

Recalled Item: Regard

The Issue: Custom procedure trays contain a component, a light

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

Class II — Potential Health HazardTerminated
January 9, 2017· Resource Optimization & Innovation Llc

Recalled Item: Regard

The Issue: Custom procedure trays contain a component, a light

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

Class II — Potential Health HazardTerminated
January 9, 2017· Resource Optimization & Innovation Llc

Recalled Item: Regard

The Issue: Custom procedure trays contain a component, a light

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

Class II — Potential Health HazardTerminated
January 9, 2017· Resource Optimization & Innovation Llc

Recalled Item: Regard

The Issue: Custom procedure trays contain a component, a light

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

Class II — Potential Health HazardTerminated
January 9, 2017· Resource Optimization & Innovation Llc

Recalled Item: Regard

The Issue: Custom procedure trays contain a component, a light

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

Class II — Potential Health HazardTerminated
January 9, 2017· Resource Optimization & Innovation Llc

Recalled Item: Regard

The Issue: Custom procedure trays contain a component, a light

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

Class II — Potential Health HazardTerminated
January 9, 2017· Aesculap Implant Systems LLC

Recalled Item: GN200 Caiman HF generators

The Issue: Generators may have a faulty component which could

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

Class II — Potential Health HazardTerminated
January 9, 2017· Advanced Sterilization Products

Recalled Item: STERRAD NX Sterilization System

The Issue: Advanced Sterilization Products (ASP) has identified that in

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

Class II — Potential Health HazardTerminated
January 8, 2017· Laerdal Medical Corporation

Recalled Item: Laerdal Compact Suction Unit ¿ 4 under the following labels:

The Issue: The On/Off functionality in the LCSU 4 is

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

Class II — Potential Health HazardTerminated
January 7, 2017· Olympus Scientific Solutions Americas

Recalled Item: Olympus Scientific Solutions Americas Corporation (OSSA) VANTA¿ XRF...

The Issue: It was discovered under rare circumstances the LED

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

Class II — Potential Health HazardTerminated
January 6, 2017· DePuy Orthopaedics, Inc.

Recalled Item: DePuy Synthes various orthopedic instruments modified by U.S. Distributors These

The Issue: Products were made outside of Quality System Regulation,

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

Class II — Potential Health HazardTerminated