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 34541–34560 of 38,428 recalls

October 14, 2013· Fresenius Medical Care Holdings, Inc.

Recalled Item: Fresenius Liberty¿ Cycler Part Number: RTLR180111 Product Usage: The Liberty

The Issue: Fluid leaking may be observed inside the pump

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

Class II — Potential Health HazardTerminated
October 13, 2013· Restoration Robotics

Recalled Item: Epsilon Skin Tensioner:Rx

The Issue: Reports of discoloration (residue) on the pins of

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

Class II — Potential Health HazardTerminated
October 13, 2013· Restoration Robotics

Recalled Item: ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384

The Issue: Reports of discoloration (residue) on the pins of

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

Class II — Potential Health HazardTerminated
October 13, 2013· Restoration Robotics

Recalled Item: ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384

The Issue: Reports of discoloration (residue) on the pins of

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

Class II — Potential Health HazardTerminated
October 13, 2013· Restoration Robotics

Recalled Item: Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067

The Issue: Reports of discoloration (residue) on the pins of

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

Class II — Potential Health HazardTerminated
October 11, 2013· Zimmer, Inc.

Recalled Item: 2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA

The Issue: Zimmer recently conducted a review of all historic

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

Class II — Potential Health HazardTerminated
October 11, 2013· Zimmer, Inc.

Recalled Item: 1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT

The Issue: Zimmer recently conducted a review of all historic

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

Class II — Potential Health HazardTerminated
October 11, 2013· Zimmer, Inc.

Recalled Item: PRESSFIT FEM ST FX 16 X 1

The Issue: Zimmer recently conducted a review of all historic

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

Class II — Potential Health HazardTerminated
October 11, 2013· Zimmer, Inc.

Recalled Item: 3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT

The Issue: Zimmer recently conducted a review of all historic

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

Class II — Potential Health HazardTerminated
October 11, 2013· Zimmer, Inc.

Recalled Item: 12/14 COCR FEMORAL HEAD (2

The Issue: Zimmer recently conducted a review of all historic

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

Class II — Potential Health HazardTerminated
October 11, 2013· Zimmer, Inc.

Recalled Item: MOORE HIP PROS LONG FENES

The Issue: Zimmer recently conducted a review of all historic

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

Class II — Potential Health HazardTerminated
October 11, 2013· Zimmer, Inc.

Recalled Item: CPT 12/14 COCR (various sizes)

The Issue: Zimmer recently conducted a review of all historic

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

Class II — Potential Health HazardTerminated
October 11, 2013· Zimmer, Inc.

Recalled Item: Bipolar liners and Multipolar cups with the following dimensions in MM (38

The Issue: Zimmer recently conducted a review of all historic

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

Class II — Potential Health HazardTerminated
October 11, 2013· Zimmer, Inc.

Recalled Item: Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting

The Issue: Zimmer recently conducted a review of all historic

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

Class II — Potential Health HazardTerminated
October 11, 2013· Zimmer, Inc.

Recalled Item: VERSA-FX KEYLESS 90D X 8 and X 11

The Issue: Zimmer recently conducted a review of all historic

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

Class II — Potential Health HazardTerminated
October 11, 2013· Zimmer, Inc.

Recalled Item: RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL

The Issue: Zimmer recently conducted a review of all historic

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

Class II — Potential Health HazardTerminated
October 11, 2013· Zimmer, Inc.

Recalled Item: 3.5 COMP PLT

The Issue: Zimmer recently conducted a review of all historic

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

Class II — Potential Health HazardTerminated
October 11, 2013· Zimmer, Inc.

Recalled Item: DISTAL MEDIAL FEMORAL CON

The Issue: Zimmer recently conducted a review of all historic

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

Class II — Potential Health HazardTerminated
October 11, 2013· Zimmer, Inc.

Recalled Item: ZIMTRON 6 DEG 22 HEADS

The Issue: Zimmer recently conducted a review of all historic

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

Class II — Potential Health HazardTerminated
October 11, 2013· Zimmer, Inc.

Recalled Item: ASIA ONE-PIECE LAG SCREW

The Issue: Zimmer recently conducted a review of all historic

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

Class II — Potential Health HazardTerminated