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 20761–20780 of 38,428 recalls

May 31, 2018· CSL Behring GmbH

Recalled Item: N Latex CDT Kit

The Issue: Siemens Healthcare Diagnostics has observed a negative bias

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

Class II — Potential Health HazardTerminated
May 31, 2018· Cook Inc.

Recalled Item: VentriClear Ventricular Drainage Catheter Set

The Issue: This lot of VentriClear failed endotoxin testing. Potential

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

Class II — Potential Health HazardTerminated
May 30, 2018· Canon Medical System, USA, INC.

Recalled Item: Nuclear Magnetic Resonance Imaging Systems that are indicated for use

The Issue: When using respiratory gating with Steady Mode ON

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

Class II — Potential Health HazardOngoing
May 30, 2018· Baxter Healthcare Corporation

Recalled Item: FLOSEAL Special Applicator Tips in cartons labeled in part

The Issue: Baxter r recalled this device due to the

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

Class II — Potential Health HazardOngoing
May 30, 2018· Siemens Medical Solutions USA, Inc

Recalled Item: ARTIS Pheno

The Issue: During manual LAO/RAO rotation at maximum speed or

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

Class II — Potential Health HazardTerminated
May 30, 2018· Zimmer Biomet, Inc.

Recalled Item: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless

The Issue: M/L Taper Hip Prosthesis and M/L Taper Hip

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

Class II — Potential Health HazardTerminated
May 30, 2018· Zimmer Biomet, Inc.

Recalled Item: Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless

The Issue: M/L Taper Hip Prosthesis and M/L Taper Hip

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

Class II — Potential Health HazardTerminated
May 30, 2018· Zimmer Biomet, Inc.

Recalled Item: Zimmer¿ M/L Taper Hip Prosthesis Plasma Sprayed

The Issue: M/L Taper Hip Prosthesis and M/L Taper Hip

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

Class II — Potential Health HazardTerminated
May 30, 2018· Zimmer Biomet, Inc.

Recalled Item: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless

The Issue: M/L Taper Hip Prosthesis and M/L Taper Hip

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

Class II — Potential Health HazardTerminated
May 30, 2018· Zimmer Biomet, Inc.

Recalled Item: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless

The Issue: M/L Taper Hip Prosthesis and M/L Taper Hip

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

Class II — Potential Health HazardTerminated
May 30, 2018· Zimmer Biomet, Inc.

Recalled Item: Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless

The Issue: M/L Taper Hip Prosthesis and M/L Taper Hip

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

Class II — Potential Health HazardTerminated
May 30, 2018· Zimmer Biomet, Inc.

Recalled Item: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless

The Issue: M/L Taper Hip Prosthesis and M/L Taper Hip

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

Class II — Potential Health HazardTerminated
May 30, 2018· Zimmer Biomet, Inc.

Recalled Item: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless

The Issue: M/L Taper Hip Prosthesis and M/L Taper Hip

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

Class II — Potential Health HazardTerminated
May 30, 2018· Zimmer Biomet, Inc.

Recalled Item: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless

The Issue: M/L Taper Hip Prosthesis and M/L Taper Hip

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

Class II — Potential Health HazardTerminated
May 30, 2018· Zimmer Biomet, Inc.

Recalled Item: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless

The Issue: M/L Taper Hip Prosthesis and M/L Taper Hip

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

Class II — Potential Health HazardTerminated
May 30, 2018· Zimmer Biomet, Inc.

Recalled Item: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless

The Issue: M/L Taper Hip Prosthesis and M/L Taper Hip

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

Class II — Potential Health HazardTerminated
May 30, 2018· Zimmer Biomet, Inc.

Recalled Item: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless

The Issue: M/L Taper Hip Prosthesis and M/L Taper Hip

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

Class II — Potential Health HazardTerminated
May 30, 2018· Zimmer Biomet, Inc.

Recalled Item: Zimmer M/L Taper Hip Prosthesis Plasma Sprayed

The Issue: M/L Taper Hip Prosthesis and M/L Taper Hip

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

Class II — Potential Health HazardTerminated
May 30, 2018· Zimmer Biomet, Inc.

Recalled Item: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless

The Issue: M/L Taper Hip Prosthesis and M/L Taper Hip

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

Class II — Potential Health HazardTerminated
May 30, 2018· Zimmer Biomet, Inc.

Recalled Item: Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless...

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

Class II — Potential Health HazardTerminated