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 29941–29960 of 38,428 recalls

June 3, 2015· Perkinelmer

Recalled Item: Perkin Elmer WIZARD2 5-detector

The Issue: Error in WIZARD2 Barcode ID Label #023 Content

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

Class II — Potential Health HazardTerminated
June 3, 2015· Perkinelmer

Recalled Item: Perkin Elmer WIZARD2 1-detector

The Issue: Error in WIZARD2 Barcode ID Label #023 Content

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

Class II — Potential Health HazardTerminated
June 3, 2015· Perkinelmer

Recalled Item: Perkin Elmer WIZARD2 10-detector

The Issue: Error in WIZARD2 Barcode ID Label #023 Content

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

Class II — Potential Health HazardTerminated
June 3, 2015· Perkinelmer

Recalled Item: WIZARD2 2-detector

The Issue: Error in WIZARD2 Barcode ID Label #023 Content

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

Class II — Potential Health HazardTerminated
June 3, 2015· Perkinelmer

Recalled Item: WIZARD2 5-detector

The Issue: Error in WIZARD2 Barcode ID Label #023 Content

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

Class II — Potential Health HazardTerminated
June 3, 2015· Omnilife Science Inc.

Recalled Item: Apex ARC Hip Stem

The Issue: Product may breach the inner and outer sterile

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

Class II — Potential Health HazardTerminated
June 3, 2015· Biomet, Inc.

Recalled Item: Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill

The Issue: Oxford Femoral Drill Guide Lateral IM Adapter may

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

Class II — Potential Health HazardTerminated
June 3, 2015· Biomet, Inc.

Recalled Item: Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation

The Issue: Part Number: 905620 Lot: 824610 Gentle Threads Interference

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

Class II — Potential Health HazardTerminated
June 3, 2015· Stryker Endoscopy

Recalled Item: SERFAS 90 degree Energy Probe

The Issue: Stryker Endoscopy is recalling all non expired SERFAS

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

Class II — Potential Health HazardTerminated
June 3, 2015· Synthes, Inc.

Recalled Item: TITANIUM END CAP WITH T40 STARDRIVE RECESS

The Issue: A specific part and lot number was packaged

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

Class II — Potential Health HazardTerminated
June 3, 2015· Biomet, Inc.

Recalled Item: Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation

The Issue: Part Number: 905620 Lot: 824610 Gentle Threads Interference

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

Class II — Potential Health HazardTerminated
June 2, 2015· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker SelectCore Variable Throw Biopsy Device

The Issue: Stryker Instruments is recalling the Stryker SelectCore Variable

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

Class II — Potential Health HazardTerminated
June 2, 2015· ArthroCare Corporation

Recalled Item: EVac 70 XTRA with Integrated Cable and PROcise EZ View

The Issue: Wands inspected with the adaptor fixture were released

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

Class II — Potential Health HazardTerminated
June 2, 2015· Alcon Research, Ltd.

Recalled Item: Accurus 2500 Standalone Vitreous Probe

The Issue: Insufficient seal on the outside packaging, potentially affecting

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

Class II — Potential Health HazardTerminated
June 2, 2015· Boston Scientific Corporation

Recalled Item: CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System

The Issue: Boston Scientific has received complaints indicating that, when

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

Class II — Potential Health HazardTerminated
June 1, 2015· Teleflex Medical

Recalled Item: HUDSON RCI

The Issue: The double swivel connector may crack or separate

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

Class I — Serious Health HazardTerminated
June 1, 2015· Teleflex Medical

Recalled Item: HUDSON RCI

The Issue: The double swivel connector may crack or separate

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

Class I — Serious Health HazardTerminated
June 1, 2015· Teleflex Medical

Recalled Item: HUDSON RCI

The Issue: The double swivel connector may crack or separate

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

Class I — Serious Health HazardTerminated
June 1, 2015· Teleflex Medical

Recalled Item: HUDSON RCI

The Issue: The double swivel connector may crack or separate

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

Class I — Serious Health HazardTerminated
June 1, 2015· Sechrist Industries Inc

Recalled Item: Sechrist Low Profile Wheeled Stretcher

The Issue: Sechrist Industries is recalling the Sechrist Low Profile

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

Class II — Potential Health HazardTerminated