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 23781–23800 of 38,428 recalls

June 6, 2017· Siemens Medical Solutions USA, Inc

Recalled Item: Artis Q and Q.Zen

The Issue: for liquid entry

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

Class II — Potential Health HazardTerminated
June 6, 2017· Siemens Medical Solutions USA, Inc

Recalled Item: Artis Zee and Zeego

The Issue: for liquid entry

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

Class II — Potential Health HazardTerminated
June 6, 2017· Spectranetics Corporation

Recalled Item: Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid...

The Issue: for flouroscopially visible marker band at the

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

Class II — Potential Health HazardTerminated
June 6, 2017· Draegar Medical Systems, Inc.

Recalled Item: Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers:

The Issue: Cockpits with revision index 06 or higher that

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

Class II — Potential Health HazardTerminated
June 5, 2017· Zimmer Biomet, Inc.

Recalled Item: M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm

The Issue: The design verification for the previous packaging configuration

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

Class II — Potential Health HazardTerminated
June 5, 2017· Zimmer Biomet, Inc.

Recalled Item: M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4

The Issue: The design verification for the previous packaging configuration

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

Class II — Potential Health HazardTerminated
June 5, 2017· Angiodynamics, Inc.

Recalled Item: Accu2i pMTA Applicator

The Issue: The firm is recalling product that has the

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

Class II — Potential Health HazardTerminated
June 5, 2017· Zimmer Biomet, Inc.

Recalled Item: Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length

The Issue: The design verification for the previous packaging configuration

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

Class II — Potential Health HazardTerminated
June 5, 2017· Angiodynamics, Inc.

Recalled Item: Accu2i pMTA Applicator

The Issue: The firm is recalling product that has the

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

Class II — Potential Health HazardTerminated
June 5, 2017· Zimmer Biomet, Inc.

Recalled Item: Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter

The Issue: The design verification for the previous packaging configuration

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

Class II — Potential Health HazardTerminated
June 5, 2017· Angiodynamics, Inc.

Recalled Item: Accu2i pMTA Applicator

The Issue: The firm is recalling product that has the

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

Class II — Potential Health HazardTerminated
June 5, 2017· Zimmer Biomet, Inc.

Recalled Item: Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter

The Issue: The design verification for the previous packaging configuration

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

Class II — Potential Health HazardTerminated
June 5, 2017· Angiodynamics, Inc.

Recalled Item: Accu2i pMTA Applicator

The Issue: The firm is recalling product that has the

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

Class II — Potential Health HazardTerminated
June 5, 2017· Angiodynamics, Inc.

Recalled Item: Accu2i pMTA Applicator

The Issue: The firm is recalling product that has the

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

Class II — Potential Health HazardTerminated
June 5, 2017· Angiodynamics, Inc.

Recalled Item: Accu2i pMTA Applicator

The Issue: The firm is recalling product that has the

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

Class II — Potential Health HazardTerminated
June 5, 2017· Zimmer Biomet, Inc.

Recalled Item: Lateral Troch Plate Full Crimp - 254mm

The Issue: Possibility that the patient label inside the product

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

Class II — Potential Health HazardTerminated
June 5, 2017· Zimmer Biomet, Inc.

Recalled Item: RED SEXP DSTL FEM 19CM RT ASSY

The Issue: Possibility that the patient label inside the product

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

Class II — Potential Health HazardTerminated
June 5, 2017· Zimmer Biomet, Inc.

Recalled Item: CER OPTION TYPE 1 TPR SLEVE -6

The Issue: Possibility that the patient label inside the product

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

Class II — Potential Health HazardTerminated
June 5, 2017· Zimmer Biomet, Inc.

Recalled Item: COMP 12MM HUM FRAC STEM MACRO

The Issue: Possibility that the patient label inside the product

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

Class II — Potential Health HazardTerminated
June 5, 2017· Zimmer Biomet, Inc.

Recalled Item: OSS CEMENTED IM STEM 12X150

The Issue: Possibility that the patient label inside the product

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

Class II — Potential Health HazardTerminated