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 35261–35280 of 38,428 recalls

June 24, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Sonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) Product...

The Issue: A supplied component exhibiting corrosion was built into

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

Class II — Potential Health HazardTerminated
June 24, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product...

The Issue: A supplied component exhibiting corrosion was built into

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

Class II — Potential Health HazardTerminated
June 24, 2013· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole)

The Issue: A supplied component exhibiting corrosion was built into

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

Class II — Potential Health HazardTerminated
June 24, 2013· Stryker Neurovascular

Recalled Item: Stryker brand Neuroform 3 Microdelivery Stent System

The Issue: The device is labeled incorrectly, in that, the

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

Class II — Potential Health HazardTerminated
June 22, 2013· Synthes USA HQ, Inc.

Recalled Item: Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage:

The Issue: A complaint was received of the tips of

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

Class II — Potential Health HazardTerminated
June 21, 2013· Genzyme Corporation, A Sanofi Company

Recalled Item: LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula Product

The Issue: Product contains particulates (fibers)

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

Class II — Potential Health HazardTerminated
June 21, 2013· Genzyme Corporation, A Sanofi Company

Recalled Item: LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is

The Issue: Product contains particulates (fibers)

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

Class II — Potential Health HazardTerminated
June 21, 2013· Genzyme Corporation, A Sanofi Company

Recalled Item: LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 LeGoo is

The Issue: Product contains particulates (fibers)

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

Class II — Potential Health HazardTerminated
June 21, 2013· Genzyme Corporation, A Sanofi Company

Recalled Item: LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 LeGoo is

The Issue: Product contains particulates (fibers)

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

Class II — Potential Health HazardTerminated
June 21, 2013· Genzyme Corporation, A Sanofi Company

Recalled Item: LeGoo¿ Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch

The Issue: Product contains particulates (fibers)

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

Class II — Potential Health HazardTerminated
June 21, 2013· Genzyme Corporation, A Sanofi Company

Recalled Item: LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is

The Issue: Product contains particulates (fibers)

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

Class II — Potential Health HazardTerminated
June 21, 2013· Genzyme Corporation, A Sanofi Company

Recalled Item: LeGoo¿ Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula

The Issue: Product contains particulates (fibers)

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

Class II — Potential Health HazardTerminated
June 21, 2013· Genzyme Corporation, A Sanofi Company

Recalled Item: LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT LeGoo

The Issue: Product contains particulates (fibers)

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

Class II — Potential Health HazardTerminated
June 21, 2013· Genzyme Corporation, A Sanofi Company

Recalled Item: LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula

The Issue: Product contains particulates (fibers)

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

Class II — Potential Health HazardTerminated
June 21, 2013· Genzyme Corporation, A Sanofi Company

Recalled Item: LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo

The Issue: Product contains particulates (fibers)

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

Class II — Potential Health HazardTerminated
June 21, 2013· Genzyme Corporation, A Sanofi Company

Recalled Item: LeGoo Endovascular Occlusion Gel 2.5 mL Product Number: LG250IT LeGoo

The Issue: Product contains particulates (fibers)

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

Class II — Potential Health HazardTerminated
June 21, 2013· Genzyme Corporation, A Sanofi Company

Recalled Item: LeGoo Internal Vessel Occluder 1mL Product Number: 10-0100 LeGoo is

The Issue: Product contains particulates (fibers)

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

Class II — Potential Health HazardTerminated
June 21, 2013· Genzyme Corporation, A Sanofi Company

Recalled Item: LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch

The Issue: Product contains particulates (fibers)

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

Class II — Potential Health HazardTerminated
June 21, 2013· Genzyme Corporation, A Sanofi Company

Recalled Item: LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch

The Issue: Product contains particulates (fibers)

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

Class II — Potential Health HazardTerminated
June 21, 2013· Genzyme Corporation, A Sanofi Company

Recalled Item: LeGoo Internal Vessel Occluder .5mL Product Number: 10-0050 LeGoo is

The Issue: Product contains particulates (fibers)

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

Class II — Potential Health HazardTerminated