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 28201–28220 of 38,428 recalls

January 11, 2016· Zimmer Biomet, Inc.

Recalled Item: NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis

The Issue: LDPE bag containing the implant adheres to the

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Biomet, Inc.

Recalled Item: NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis

The Issue: LDPE bag containing the implant adheres to the

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Biomet, Inc.

Recalled Item: CR Flex GSF Precoat Fem Natural Knee GSF NP Flex

The Issue: LDPE bag containing the implant adheres to the

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Biomet, Inc.

Recalled Item: CPT 12/14 COCR prosthesis

The Issue: LDPE bag containing the implant adheres to the

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Biomet, Inc.

Recalled Item: NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis

The Issue: LDPE bag containing the implant adheres to the

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Biomet, Inc.

Recalled Item: VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED

The Issue: LDPE bag containing the implant adheres to the

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Biomet, Inc.

Recalled Item: NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX

The Issue: LDPE bag containing the implant adheres to the

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Biomet, Inc.

Recalled Item: VERSYS 6 INCH BEADED FC 1 prosthesis

The Issue: LDPE bag containing the implant adheres to the

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Biomet, Inc.

Recalled Item: VERSYS 7.5 INCH BEADED FC prosthesis

The Issue: LDPE bag containing the implant adheres to the

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Biomet, Inc.

Recalled Item: Metasul Head 40

The Issue: LDPE bag containing the implant adheres to the

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Biomet, Inc.

Recalled Item: CPT 12/14 COCR prosthesis

The Issue: LDPE bag containing the implant adheres to the

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Biomet, Inc.

Recalled Item: NKII CSTI Porous Femoral NKII NP Femoral prosthesis

The Issue: LDPE bag containing the implant adheres to the

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

Class II — Potential Health HazardTerminated
January 11, 2016· Medtronic Neuromodulation

Recalled Item: Specify 5-6-5 Lead

The Issue: Some Specify 5-6-5 and 2x8 surgical lead product

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Biomet, Inc.

Recalled Item: Bipolar Shell prosthesis

The Issue: LDPE bag containing the implant adheres to the

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Biomet, Inc.

Recalled Item: VERSYS 6 INCH BEADED FC 1 prosthesis

The Issue: LDPE bag containing the implant adheres to the

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Biomet, Inc.

Recalled Item: PRCT MIS CR MOB PLT prosthesis

The Issue: LDPE bag containing the implant adheres to the

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Biomet, Inc.

Recalled Item: CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral

The Issue: LDPE bag containing the implant adheres to the

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Biomet, Inc.

Recalled Item: LPS-FLEX GSF OPT prosthesis

The Issue: LDPE bag containing the implant adheres to the

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Biomet, Inc.

Recalled Item: NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM

The Issue: LDPE bag containing the implant adheres to the

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Biomet, Inc.

Recalled Item: ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis

The Issue: LDPE bag containing the implant adheres to the

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

Class II — Potential Health HazardTerminated