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 30581–30600 of 38,428 recalls

April 16, 2015· Covidien LLC

Recalled Item: Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog...

The Issue: Devon Light Gloves contain splits or holes compromising

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

Class II — Potential Health HazardTerminated
April 16, 2015· Covidien LLC

Recalled Item: Delivery/C-Section

The Issue: Devon Light Gloves contain splits or holes compromising

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

Class II — Potential Health HazardTerminated
April 16, 2015· Covidien LLC

Recalled Item: NS-3600-B LITE GLOVE 1000/CASE -Bulk

The Issue: Devon Light Gloves contain splits or holes compromising

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

Class II — Potential Health HazardTerminated
April 16, 2015· Covidien LLC

Recalled Item: Surgical Set Up kit

The Issue: Devon Light Gloves contain splits or holes compromising

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

Class II — Potential Health HazardTerminated
April 16, 2015· Biomet, Inc.

Recalled Item: Comprehensive Shoulder System

The Issue: Biomet hip joint, knee joint and shoulder joint

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

Class III — Low RiskTerminated
April 16, 2015· Biomet, Inc.

Recalled Item: Biomet Cobalt-Chrome Femoral Components

The Issue: Biomet hip joint, knee joint and shoulder joint

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

Class III — Low RiskTerminated
April 16, 2015· Biomet, Inc.

Recalled Item: Mallory/Head Primary Hip System

The Issue: Biomet hip joint, knee joint and shoulder joint

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

Class III — Low RiskTerminated
April 16, 2015· Biomet, Inc.

Recalled Item: MCK Maximum Congruent Knee System

The Issue: Biomet hip joint, knee joint and shoulder joint

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

Class III — Low RiskTerminated
April 16, 2015· Medtronic Neuromodulation

Recalled Item: Medtronic DBS Extension Kit for Deep Brain Stimulation

The Issue: Medtronic is providing Important information regarding extension handling

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

Class II — Potential Health HazardTerminated
April 16, 2015· Wright Medical Technology, Inc.

Recalled Item: PHALINX (TM) HAMMERTOE HANDLE

The Issue: The term DORSAL was laser etched on the

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

Class II — Potential Health HazardTerminated
April 16, 2015· Wright Medical Technology, Inc.

Recalled Item: PHALINX (TM) HAMMERTOE HANDLE

The Issue: The term DORSAL was laser etched on the

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

Class II — Potential Health HazardTerminated
April 16, 2015· Wright Medical Technology, Inc.

Recalled Item: PHALINX (TM) HAMMERTOE HANDLE

The Issue: The term DORSAL was laser etched on the

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

Class II — Potential Health HazardTerminated
April 16, 2015· Wright Medical Technology, Inc.

Recalled Item: PHALINX (TM) HAMMERTOE HANDLE

The Issue: The term DORSAL was laser etched on the

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

Class II — Potential Health HazardTerminated
April 16, 2015· BioHorizons Implant Systems Inc

Recalled Item: Tapered HD Upgrade Set

The Issue: BioHorizons Tapered HD Upgrade set was packaged with

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

Class II — Potential Health HazardTerminated
April 15, 2015· Alcon Research, Ltd.

Recalled Item: ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon

The Issue: There are reports of post - operative inflammation

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

Class I — Serious Health HazardTerminated
April 14, 2015· Philips Electronics North America Corporation

Recalled Item: Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system

The Issue: During scans with specific protocol steps, the software

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

Class II — Potential Health HazardTerminated
April 14, 2015· Philips Electronics North America Corporation

Recalled Item: Philips Healthcare Ingenuity Core Computed Tomography X-ray system

The Issue: During scans with specific protocol steps, the software

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

Class II — Potential Health HazardTerminated
April 14, 2015· Philips Electronics North America Corporation

Recalled Item: Philips Healthcare Ingenuity CT Computed Tomography X-ray system

The Issue: During scans with specific protocol steps, the software

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

Class II — Potential Health HazardTerminated
April 14, 2015· Philips Electronics North America Corporation

Recalled Item: Philips Healthcare Brilliance 64 Computed Tomography X-ray system

The Issue: During scans with specific protocol steps, the software

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

Class II — Potential Health HazardTerminated
April 14, 2015· Halyard Health, Inc

Recalled Item: KimVent Turbo-Cleaning Closed Suction System for Adults

The Issue: The internal blue flapper valve of certain KimVent

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

Class II — Potential Health HazardTerminated