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 13601–13620 of 38,428 recalls

December 1, 2020· Biomet, Inc.

Recalled Item: Vanguard 360 Revision System Posterior Augment With Bolt - Product

The Issue: Incorrect bolt -tibial bolts in package instead of

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

Class II — Potential Health HazardTerminated
November 30, 2020· Siemens Medical Solutions USA, Inc

Recalled Item: Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno

The Issue: When the user changes frame rates from lower

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

Class II — Potential Health HazardOngoing
November 25, 2020· Biomet, Inc.

Recalled Item: 3.0mm Cannulated Screw System

The Issue: Specific lots of multiple sterile medical devices may

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

Class II — Potential Health HazardTerminated
November 25, 2020· Biomet, Inc.

Recalled Item: Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System

The Issue: Specific lots of multiple sterile medical devices may

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

Class II — Potential Health HazardTerminated
November 25, 2020· Biomet, Inc.

Recalled Item: Oxford Fixed Lateral

The Issue: Specific lots of multiple sterile medical devices may

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

Class II — Potential Health HazardTerminated
November 25, 2020· Biomet, Inc.

Recalled Item: Custom Cancellous Thread

The Issue: Specific lots of multiple sterile medical devices may

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

Class II — Potential Health HazardTerminated
November 25, 2020· Biomet, Inc.

Recalled Item: Sterile Trac System Thinflap 24 MM Burr Hole Plate

The Issue: Specific lots of multiple sterile medical devices may

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

Class II — Potential Health HazardTerminated
November 25, 2020· Biomet, Inc.

Recalled Item: PHOENIX

The Issue: Specific lots of multiple sterile medical devices may

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

Class II — Potential Health HazardTerminated
November 25, 2020· Biomet, Inc.

Recalled Item: M/H MODULAR STEM

The Issue: Specific lots of multiple sterile medical devices may

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

Class II — Potential Health HazardTerminated
November 25, 2020· Biomet, Inc.

Recalled Item: OSS Polyethylene Tibial Bushing

The Issue: Specific lots of multiple sterile medical devices may

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

Class II — Potential Health HazardTerminated
November 25, 2020· Biomet, Inc.

Recalled Item: RINGLOC BIPOLAR Hip System Bi Polar Locking Ring

The Issue: Specific lots of multiple sterile medical devices may

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

Class II — Potential Health HazardTerminated
November 25, 2020· Biomet, Inc.

Recalled Item: Comprehensive Reverse Shoulder System

The Issue: Specific lots of multiple sterile medical devices may

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

Class II — Potential Health HazardTerminated
November 25, 2020· Biomet, Inc.

Recalled Item: 4.0/5.0mm Cannulated Screw System

The Issue: Specific lots of multiple sterile medical devices may

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

Class II — Potential Health HazardTerminated
November 25, 2020· Biomet, Inc.

Recalled Item: RINGLOC ACETABULAR SYSTEM Self-tapping bone screws

The Issue: Specific lots of multiple sterile medical devices may

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

Class II — Potential Health HazardTerminated
November 25, 2020· Biomet, Inc.

Recalled Item: 6.5/8.0mm Cannulated Screw System

The Issue: Specific lots of multiple sterile medical devices may

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

Class II — Potential Health HazardTerminated
November 25, 2020· Biomet, Inc.

Recalled Item: Titanium IFS

The Issue: Specific lots of multiple sterile medical devices may

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

Class II — Potential Health HazardTerminated
November 25, 2020· Biomet, Inc.

Recalled Item: RingLoc+ Quick Connect Drill Bit

The Issue: Specific lots of multiple sterile medical devices may

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

Class II — Potential Health HazardTerminated
November 25, 2020· Biomet, Inc.

Recalled Item: RapidFire Clip

The Issue: Specific lots of multiple sterile medical devices may

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

Class II — Potential Health HazardTerminated
November 24, 2020· Siemens Medical Solutions USA, Inc

Recalled Item: SOMATOM Force

The Issue: System does not trigger a cancel command followed

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

Class II — Potential Health HazardTerminated
November 24, 2020· Cook Inc.

Recalled Item: Flexor Check-Flo Introducer

The Issue: There is an increased likelihood of the introducer

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

Class I — Serious Health HazardTerminated