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 20601–20620 of 38,428 recalls

June 22, 2018· Stryker Leibinger GmbH & Co. KG

Recalled Item: AXS PP

The Issue: After a three year term, there is a

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

Class II — Potential Health HazardTerminated
June 22, 2018· Stryker Leibinger GmbH & Co. KG

Recalled Item: QUIKFLAP

The Issue: After a three year term, there is a

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

Class II — Potential Health HazardTerminated
June 22, 2018· Stryker Leibinger GmbH & Co. KG

Recalled Item: QUIKFLAP

The Issue: After a three year term, there is a

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

Class II — Potential Health HazardTerminated
June 22, 2018· Stryker Leibinger GmbH & Co. KG

Recalled Item: AXS PP

The Issue: After a three year term, there is a

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

Class II — Potential Health HazardTerminated
June 22, 2018· Stryker Leibinger GmbH & Co. KG

Recalled Item: AXS PP

The Issue: After a three year term, there is a

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

Class II — Potential Health HazardTerminated
June 22, 2018· Stryker Leibinger GmbH & Co. KG

Recalled Item: AXS PP

The Issue: After a three year term, there is a

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

Class II — Potential Health HazardTerminated
June 22, 2018· Stryker Leibinger GmbH & Co. KG

Recalled Item: QUIKFLAP

The Issue: After a three year term, there is a

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

Class II — Potential Health HazardTerminated
June 22, 2018· Stryker Leibinger GmbH & Co. KG

Recalled Item: QUIKFLAP

The Issue: After a three year term, there is a

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

Class II — Potential Health HazardTerminated
June 22, 2018· Stryker Leibinger GmbH & Co. KG

Recalled Item: QUIKFLAP

The Issue: After a three year term, there is a

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

Class II — Potential Health HazardTerminated
June 22, 2018· Stryker Leibinger GmbH & Co. KG

Recalled Item: QUIKFLAP

The Issue: After a three year term, there is a

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

Class II — Potential Health HazardTerminated
June 22, 2018· Zimmer Biomet, Inc.

Recalled Item: Persona Partial Knee System Spacer Block Alignment Tower

The Issue: The PPK System Spacer Block Alignment Tower mating

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

Class II — Potential Health HazardTerminated
June 22, 2018· Clarity Diagnostics Llc

Recalled Item: Clarity Urocheck 10SG Urinalysis Strips

The Issue: Clarity Diagnostics LLC discovered specific lots of Clarity

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

Class III — Low RiskTerminated
June 22, 2018· Siemens Medical Solutions USA, Inc

Recalled Item: Artis Q. angiography system. Model 10848280

The Issue: hardware issue which may cause thermal effects

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

Class II — Potential Health HazardTerminated
June 21, 2018· Baxter Healthcare Corporation

Recalled Item: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)

The Issue: The flow rate test verification was not properly

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

Class II — Potential Health HazardTerminated
June 21, 2018· Ossur Americas

Recalled Item: Ossur Skull Pin

The Issue: Halo system products labeled MR conditional will undergo

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

Class II — Potential Health HazardTerminated
June 21, 2018· Ossur Americas

Recalled Item: Ossur

The Issue: Halo system products labeled MR conditional will undergo

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

Class II — Potential Health HazardTerminated
June 21, 2018· Ossur Americas

Recalled Item: Ossur CB Resolve

The Issue: Halo system products labeled MR conditional will undergo

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

Class II — Potential Health HazardTerminated
June 21, 2018· Ossur Americas

Recalled Item: Ossur OB Resolve

The Issue: Halo system products labeled MR conditional will undergo

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

Class II — Potential Health HazardTerminated
June 21, 2018· Ossur Americas

Recalled Item: Ossur Skull Pin

The Issue: Halo system products labeled MR conditional will undergo

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

Class II — Potential Health HazardTerminated
June 21, 2018· Ossur Americas

Recalled Item: Ossur

The Issue: Halo system products labeled MR conditional will undergo

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

Class II — Potential Health HazardTerminated