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 36561–36580 of 38,428 recalls

December 3, 2012· Quidel Corporation

Recalled Item: Quidel

The Issue: Quidel Corporation has initiated a voluntary recall of

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

Class II — Potential Health HazardTerminated
December 3, 2012· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems:

The Issue: Software anomalies. Philips Medical Systems recalled their Brilliance

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

Class II — Potential Health HazardTerminated
December 3, 2012· DePuy Orthopaedics, Inc.

Recalled Item: SOL SYS 8IN CALC 1.5/18.0 Packaging: Product is packed within

The Issue: An Engineering Analysis has determined the Solution Calcar

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

Class II — Potential Health HazardTerminated
December 3, 2012· DePuy Orthopaedics, Inc.

Recalled Item: SOL SYS L 9IN CALC 2.25/15.0 Packaging: Product is packed

The Issue: An Engineering Analysis has determined the Solution Calcar

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

Class II — Potential Health HazardTerminated
December 3, 2012· DePuy Orthopaedics, Inc.

Recalled Item: SOL SYS R 9IN CALC 2.25/16.5 Packaging: Product is packed

The Issue: An Engineering Analysis has determined the Solution Calcar

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

Class II — Potential Health HazardTerminated
December 3, 2012· DePuy Orthopaedics, Inc.

Recalled Item: SOL SYS 8IN CALC 1.5/19.5 Packaging: Product is packed within

The Issue: An Engineering Analysis has determined the Solution Calcar

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

Class II — Potential Health HazardTerminated
December 3, 2012· DePuy Orthopaedics, Inc.

Recalled Item: SOL SYS L 9IN CALC 2.25/19.5 Packaging: Product is packed

The Issue: An Engineering Analysis has determined the Solution Calcar

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

Class II — Potential Health HazardTerminated
December 3, 2012· Medtronic Neuromodulation

Recalled Item: Medtronic

The Issue: Medtronic has identified 140 Restore DBS Extension Kits

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

Class II — Potential Health HazardTerminated
December 3, 2012· DePuy Orthopaedics, Inc.

Recalled Item: SOL SYS F 8 CALC 13.5MM LG Packaging: Product is

The Issue: An Engineering Analysis has determined the Solution Calcar

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

Class II — Potential Health HazardTerminated
December 3, 2012· DePuy Orthopaedics, Inc.

Recalled Item: SOL SYS R 9IN CALC 2.25/18 Packaging: Product is packed

The Issue: An Engineering Analysis has determined the Solution Calcar

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

Class II — Potential Health HazardTerminated
December 3, 2012· DePuy Orthopaedics, Inc.

Recalled Item: SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed

The Issue: An Engineering Analysis has determined the Solution Calcar

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

Class II — Potential Health HazardTerminated
December 3, 2012· DePuy Orthopaedics, Inc.

Recalled Item: SOL SYS R 9IN CALC 2.25/19.5 Packaging: Product is packed

The Issue: An Engineering Analysis has determined the Solution Calcar

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

Class II — Potential Health HazardTerminated
December 3, 2012· DePuy Orthopaedics, Inc.

Recalled Item: SOL SYS L 9IN CALC 2.25/22.5 Packaging: Product is packed

The Issue: An Engineering Analysis has determined the Solution Calcar

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

Class II — Potential Health HazardTerminated
December 3, 2012· DePuy Orthopaedics, Inc.

Recalled Item: SOL SYS F 9 CALC L 13.5MM LG Packaging: Product

The Issue: An Engineering Analysis has determined the Solution Calcar

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

Class II — Potential Health HazardTerminated
December 3, 2012· DePuy Orthopaedics, Inc.

Recalled Item: SOL SYS R 9IN CALC 2.25/15.0 Packaging: Product is packed

The Issue: An Engineering Analysis has determined the Solution Calcar

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

Class II — Potential Health HazardTerminated
December 3, 2012· DePuy Orthopaedics, Inc.

Recalled Item: SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within

The Issue: An Engineering Analysis has determined the Solution Calcar

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

Class II — Potential Health HazardTerminated
December 3, 2012· DePuy Orthopaedics, Inc.

Recalled Item: SOL SYS L 9IN CALC 2.25/18 Packaging: Product is packed

The Issue: An Engineering Analysis has determined the Solution Calcar

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

Class II — Potential Health HazardTerminated
December 3, 2012· DePuy Orthopaedics, Inc.

Recalled Item: SOL SYS 8IN CALC 1.5/15.0 Packaging: Product is packed within

The Issue: An Engineering Analysis has determined the Solution Calcar

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

Class II — Potential Health HazardTerminated
December 3, 2012· DePuy Orthopaedics, Inc.

Recalled Item: SOL SYS L 9IN CALC 2.25/21 Packaging: Product is packed

The Issue: An Engineering Analysis has determined the Solution Calcar

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

Class II — Potential Health HazardTerminated
December 3, 2012· DePuy Orthopaedics, Inc.

Recalled Item: SOL SYS R 9IN CALC 2.25/22.5 Packaging: Product is packed

The Issue: An Engineering Analysis has determined the Solution Calcar

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

Class II — Potential Health HazardTerminated