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 16681–16700 of 38,428 recalls

October 10, 2019· Zimmer Biomet, Inc.

Recalled Item: CABLE-READY SHORT GTR and CABLE-READY LONG GTR

The Issue: Non-highly polished implants may adhere to the LDPE

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

Class II — Potential Health HazardTerminated
October 10, 2019· Zimmer Biomet, Inc.

Recalled Item: Periarticular locking plate elbow-sterile

The Issue: Non-highly polished implants may adhere to the LDPE

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

Class II — Potential Health HazardTerminated
October 10, 2019· Zimmer Biomet, Inc.

Recalled Item: TM Ankle and Ankle Talus L/R

The Issue: Non-highly polished implants may adhere to the LDPE

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

Class II — Potential Health HazardTerminated
October 10, 2019· Zimmer Biomet, Inc.

Recalled Item: Metasul Taper Liner

The Issue: Non-highly polished implants may adhere to the LDPE

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

Class II — Potential Health HazardTerminated
October 10, 2019· Zimmer Biomet, Inc.

Recalled Item: Various Surgical Instruments: Screws and Reamers

The Issue: Non-highly polished implants may adhere to the LDPE

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

Class II — Potential Health HazardTerminated
October 10, 2019· Zimmer Biomet, Inc.

Recalled Item: Periarticulare Plates - Elbow

The Issue: Non-highly polished implants may adhere to the LDPE

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

Class II — Potential Health HazardTerminated
October 10, 2019· Zimmer Biomet, Inc.

Recalled Item: Sidus Stem-Free Shoulder Humeral Head

The Issue: Non-highly polished implants may adhere to the LDPE

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

Class II — Potential Health HazardTerminated
October 10, 2019· Zimmer Biomet, Inc.

Recalled Item: PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL

The Issue: Non-highly polished implants may adhere to the LDPE

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

Class II — Potential Health HazardTerminated
October 10, 2019· Zimmer Biomet, Inc.

Recalled Item: Trabecular Metal Reverse Shoulder System

The Issue: Non-highly polished implants may adhere to the LDPE

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

Class II — Potential Health HazardTerminated
October 10, 2019· Zimmer Biomet, Inc.

Recalled Item: Fitmore Hip Stem

The Issue: Non-highly polished implants may adhere to the LDPE

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

Class II — Potential Health HazardTerminated
October 10, 2019· Zimmer Biomet, Inc.

Recalled Item: Coorad Morrey Total Elbow

The Issue: Non-highly polished implants may adhere to the LDPE

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

Class II — Potential Health HazardTerminated
October 10, 2019· Zimmer Biomet, Inc.

Recalled Item: Various Hip Joint Replacement Systems

The Issue: Non-highly polished implants may adhere to the LDPE

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

Class II — Potential Health HazardTerminated
October 10, 2019· Zimmer Biomet, Inc.

Recalled Item: Various Custom Devices

The Issue: Non-highly polished implants may adhere to the LDPE

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

Class II — Potential Health HazardTerminated
October 10, 2019· Zimmer Biomet, Inc.

Recalled Item: NCB Proximal Lateral Tibia

The Issue: Non-highly polished implants may adhere to the LDPE

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

Class II — Potential Health HazardTerminated
October 10, 2019· Zimmer Biomet, Inc.

Recalled Item: SM DIS VOL/DORS RAD LAT COL PLATE

The Issue: Non-highly polished implants may adhere to the LDPE

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

Class II — Potential Health HazardTerminated
October 9, 2019· Stryker Sustainability Solutions

Recalled Item: Zimmer Tourniquet Cuff 30" (Blue)

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
October 9, 2019· Medivators, Inc.

Recalled Item: Medivators Endo Smartcap Endoscope Tubing.

The Issue: Medivators is recalling Endo SmartCap Tubing due to

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

Class II — Potential Health HazardTerminated
October 9, 2019· Medivators, Inc.

Recalled Item: Medivators Endo carry-on Procedure Kit - Product Usage:

The Issue: Medivators is recalling Endo SmartCap Tubing due to

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

Class II — Potential Health HazardTerminated
October 9, 2019· Medivators, Inc.

Recalled Item: Medivators EndoGator . Kit for Olympus 140/160/180/190 Series GI

The Issue: Medivators is recalling Endo SmartCap Tubing due to

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

Class II — Potential Health HazardTerminated
October 9, 2019· Medivators, Inc.

Recalled Item: Medivators EndoGator . Kit for Olympus 140/160/180/190 Series GI

The Issue: Medivators is recalling Endo SmartCap Tubing due to

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

Class II — Potential Health HazardTerminated