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 37121–37140 of 38,428 recalls

September 5, 2012· Wright Medical Technology Inc

Recalled Item: Knee Components: ROTULE "913" D=32

The Issue: There may be inaccuracies on the labeled shelf

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

Class II — Potential Health HazardTerminated
September 5, 2012· Zimmer, Inc.

Recalled Item: ATS 3000 Automatic Tourniquet System w/HOSES AND LOP SENSOR Intended

The Issue: Zimmer is conducting a voluntary removal of some

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

Class II — Potential Health HazardTerminated
September 5, 2012· Wright Medical Technology Inc

Recalled Item: Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM

The Issue: There may be inaccuracies on the labeled shelf

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

Class II — Potential Health HazardTerminated
September 5, 2012· Wright Medical Technology Inc

Recalled Item: Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28

The Issue: There may be inaccuracies on the labeled shelf

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

Class II — Potential Health HazardTerminated
September 4, 2012· Zimmer, Inc.

Recalled Item: CLS Stem

The Issue: Zimmer Inc., is initiating a correction to the

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

Class II — Potential Health HazardTerminated
September 4, 2012· Zimmer, Inc.

Recalled Item: DTO" Implant

The Issue: Zimmer Inc., is initiating a correction to the

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

Class II — Potential Health HazardTerminated
September 4, 2012· Zimmer, Inc.

Recalled Item: Dynesys¿ Top-Loading System Cannulated Pedicle + Set Screw

The Issue: Zimmer Inc., is initiating a correction to the

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

Class II — Potential Health HazardTerminated
September 4, 2012· Zimmer, Inc.

Recalled Item: Anatomical Shoulder" Fracture Humeral stem

The Issue: Zimmer Inc., is initiating a correction to the

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

Class II — Potential Health HazardTerminated
September 4, 2012· Zimmer, Inc.

Recalled Item: Alloclassic SL Shaft

The Issue: Zimmer Inc., is initiating a correction to the

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

Class II — Potential Health HazardTerminated
September 4, 2012· Zimmer, Inc.

Recalled Item: NCB¿ screw ¿ 4.0 self-tapping

The Issue: Zimmer Inc., is initiating a correction to the

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

Class II — Potential Health HazardTerminated
September 4, 2012· Zimmer, Inc.

Recalled Item: Anatomical Shoulder" Inverse/Reverse Humeral PE-Insert Sterile

The Issue: Zimmer Inc., is initiating a correction to the

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

Class II — Potential Health HazardTerminated
September 4, 2012· Zimmer, Inc.

Recalled Item: Biolox¿ Option Ceramic Femoral Head System Rx

The Issue: Zimmer Inc., is initiating a correction to the

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

Class II — Potential Health HazardTerminated
September 4, 2012· Zimmer, Inc.

Recalled Item: zimmer Anatomical Shoulder Glenoid S

The Issue: Zimmer Inc., is initiating a correction to the

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

Class II — Potential Health HazardTerminated
September 4, 2012· Zimmer, Inc.

Recalled Item: Anatomical Shoulder" Inverse Humeral Cup

The Issue: Zimmer Inc., is initiating a correction to the

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

Class II — Potential Health HazardTerminated
September 4, 2012· Zimmer, Inc.

Recalled Item: Anatomical Shoulder" Inverse/Reverse Glenoid Sterile

The Issue: Zimmer Inc., is initiating a correction to the

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

Class II — Potential Health HazardTerminated
September 4, 2012· Zimmer, Inc.

Recalled Item: Dynesys¿ Revision + set screw

The Issue: Zimmer Inc., is initiating a correction to the

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

Class II — Potential Health HazardTerminated
September 4, 2012· Zimmer, Inc.

Recalled Item: MS-30¿ Stem

The Issue: Zimmer Inc., is initiating a correction to the

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

Class II — Potential Health HazardTerminated
September 4, 2012· Zimmer, Inc.

Recalled Item: Anatomical Shoulder" Humeral stem

The Issue: Zimmer Inc., is initiating a correction to the

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

Class II — Potential Health HazardTerminated
September 4, 2012· Zimmer, Inc.

Recalled Item: MS-30¿ Distal centralizer

The Issue: Zimmer Inc., is initiating a correction to the

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

Class II — Potential Health HazardTerminated
September 4, 2012· Zimmer, Inc.

Recalled Item: Original M.E. Mueller" Low Profile Cup Sterile

The Issue: Zimmer Inc., is initiating a correction to the

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

Class II — Potential Health HazardTerminated