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 34421–34440 of 38,428 recalls

November 5, 2013· ASI Medical, Inc.

Recalled Item: SEAC Advanced Dental System

The Issue: ASI Medical is initiating a field correction for

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

Class II — Potential Health HazardTerminated
November 5, 2013· Boston Scientific Corporation

Recalled Item: Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280

The Issue: The 13F/15F Navigator HD Ureteral Access SheathSet are

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

Class II — Potential Health HazardTerminated
November 5, 2013· Boston Scientific Corporation

Recalled Item: Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280

The Issue: The 13F/15F Navigator HD Ureteral Access SheathSet are

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

Class II — Potential Health HazardTerminated
November 5, 2013· Boston Scientific Corporation

Recalled Item: Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270

The Issue: The 13F/15F Navigator HD Ureteral Access SheathSet are

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

Class II — Potential Health HazardTerminated
November 4, 2013· Medline Industries Inc

Recalled Item: Mucus Specimen Trap 40 cc

The Issue: There is a potential that the specified mucus

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

Class II — Potential Health HazardTerminated
November 4, 2013· Zimmer, Inc.

Recalled Item: Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin)

The Issue: The patient label associated with the product may

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

Class II — Potential Health HazardTerminated
November 4, 2013· Stryker Neurovascular

Recalled Item: Stryker brand COMPLIANT 4MM X 30MM

The Issue: Products were shipped labeled with "use by" dates

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

Class II — Potential Health HazardTerminated
November 4, 2013· Stryker Neurovascular

Recalled Item: Stryker brand SUPER COMPLIANT 7MM X 15MM

The Issue: Products were shipped labeled with "use by" dates

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

Class II — Potential Health HazardTerminated
November 4, 2013· Stryker Neurovascular

Recalled Item: Stryker brand EXCELSIOR SL-10 150CM 2 TIP

The Issue: Products were shipped labeled with "use by" dates

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

Class II — Potential Health HazardTerminated
November 4, 2013· Stryker Neurovascular

Recalled Item: Stryker brand GDC-18 360 18MM X 30CM

The Issue: Products were shipped labeled with "use by" dates

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

Class II — Potential Health HazardTerminated
November 4, 2013· Stryker Neurovascular

Recalled Item: Stryker brand COMPLIANT 4MM X 20MM

The Issue: Products were shipped labeled with "use by" dates

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

Class II — Potential Health HazardTerminated
November 4, 2013· Stryker Neurovascular

Recalled Item: Stryker brand COMPLIANT 5MM X 30MM

The Issue: Products were shipped labeled with "use by" dates

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

Class II — Potential Health HazardTerminated
November 4, 2013· Stryker Neurovascular

Recalled Item: Stryker brand COMPLIANT 4MM X 10MM

The Issue: Products were shipped labeled with "use by" dates

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

Class II — Potential Health HazardTerminated
November 4, 2013· Stryker Neurovascular

Recalled Item: Stryker brand GDC-10 ULTRA SOFT 2MM X 3CM

The Issue: Products were shipped labeled with "use by" dates

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

Class II — Potential Health HazardTerminated
November 4, 2013· Stryker Neurovascular

Recalled Item: Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM

The Issue: Products were shipped labeled with "use by" dates

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

Class II — Potential Health HazardTerminated
November 4, 2013· Stryker Neurovascular

Recalled Item: Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM

The Issue: Products were shipped labeled with "use by" dates

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

Class II — Potential Health HazardTerminated
November 4, 2013· Stryker Neurovascular

Recalled Item: Stryker brand EXCELSIOR SL-10 PRE-SHAPED 45 150CM

The Issue: Products were shipped labeled with "use by" dates

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

Class II — Potential Health HazardTerminated
November 4, 2013· Stryker Neurovascular

Recalled Item: Stryker brand COMPLIANT 5MM X 15MM

The Issue: Products were shipped labeled with "use by" dates

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

Class II — Potential Health HazardTerminated
November 4, 2013· Stryker Neurovascular

Recalled Item: Stryker brand GDC VORTX 2MM X 3MM

The Issue: Products were shipped labeled with "use by" dates

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

Class II — Potential Health HazardTerminated
November 4, 2013· Stryker Neurovascular

Recalled Item: Stryker brand EXCELSIOR SL-10 PRE-SHAPED S 15OCM

The Issue: Products were shipped labeled with "use by" dates

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

Class II — Potential Health HazardTerminated