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 36581–36600 of 38,428 recalls

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 L 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 CALCAR SZ12 Packaging: Product is packed within a poly protector

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
November 30, 2012· Biomet Spine, LLC

Recalled Item: Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage:

The Issue: Biomet Spine LLC is recalling the Set Screw

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

Class II — Potential Health HazardTerminated
November 30, 2012· St. Jude Medical

Recalled Item: Eon and Eon Mini charging system

The Issue: There is issues of warmth or heating at

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

Class II — Potential Health HazardTerminated
November 29, 2012· Handicare Accessibility

Recalled Item: Handset component of the Handicare USA's Minivator Bath Bliss Reclining

The Issue: Firm became aware that two handsets in the

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

Class II — Potential Health HazardTerminated
November 29, 2012· Thermo Fisher Scientific (Asheville) LLC

Recalled Item: CO2 Incubators (General Purpose Incubator)

The Issue: Incubators manufactured prior to mid 2009 have coated

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

Class II — Potential Health HazardTerminated
November 28, 2012· Philips Healthcare Inc.

Recalled Item: Mobile Diagnostic X-Ray System with Digital Panel

The Issue: When the operator moves an image to another

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

Class II — Potential Health HazardTerminated
November 28, 2012· The Binding Site Group, Ltd.

Recalled Item: Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids

The Issue: Calibration curve activity has increased over time in

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

Class II — Potential Health HazardTerminated
November 28, 2012· The Anspach Effort, Inc.

Recalled Item: ANSPACH******2.37mm Spiral Drill

The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,

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

Class II — Potential Health HazardTerminated
November 28, 2012· The Anspach Effort, Inc.

Recalled Item: ANSPACH******Threaders

The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,

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

Class II — Potential Health HazardTerminated
November 28, 2012· The Anspach Effort, Inc.

Recalled Item: ANSPACH******Custom Autolube Food Guard***Rx Only*** This device is intended

The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,

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

Class II — Potential Health HazardTerminated
November 28, 2012· The Anspach Effort, Inc.

Recalled Item: ANSPACH***MA Attachment

The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,

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

Class II — Potential Health HazardTerminated
November 28, 2012· The Anspach Effort, Inc.

Recalled Item: ANSPACH******eMax 2 Modified Hand Control***Rx Only*** This device is

The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,

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

Class II — Potential Health HazardTerminated
November 28, 2012· The Anspach Effort, Inc.

Recalled Item: ANSPACH***Custom QD11 Attachment with thinner nose tube***Rx Only*** This device

The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,

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

Class II — Potential Health HazardTerminated
November 28, 2012· The Anspach Effort, Inc.

Recalled Item: ANSPACH******Custom 5 cm Extension Bearing Sleeve***Rx Only*** This device

The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,

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

Class II — Potential Health HazardTerminated
November 28, 2012· The Anspach Effort, Inc.

Recalled Item: ANSPACH***Modified QD11 Attachment with Soft Tissue Protector***Rx Only***...

The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,

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

Class II — Potential Health HazardTerminated
November 28, 2012· The Anspach Effort, Inc.

Recalled Item: ANSPACH******3mm Fluted Ball for Adjustable 25cm Mia Attachment***Rx Only***

The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,

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

Class II — Potential Health HazardTerminated
November 28, 2012· The Anspach Effort, Inc.

Recalled Item: ANSPACH******13 mm Drill with Depth Stop for Short Heavy

The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,

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

Class II — Potential Health HazardTerminated
November 28, 2012· The Anspach Effort, Inc.

Recalled Item: ANSPACH******8 mm Coarse Headless Screw with Driver***Rx Only*** This

The Issue: The Anspach Effort, Inc. in Palm Beach Gardens,

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

Class II — Potential Health HazardTerminated