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 461–480 of 38,428 recalls

November 26, 2025· Medline Industries, LP

Recalled Item: Medline Kits containing B. Braun IV Administration Sets and Pump

The Issue: Medline kits contain B. Braun IV Administration Sets

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

Class II — Potential Health HazardOngoing
November 26, 2025· Medline Industries, LP

Recalled Item: Medline Kits containing B. Braun IV Administration Sets and Pump

The Issue: Medline kits contain B. Braun IV Administration Sets

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

Class II — Potential Health HazardOngoing
November 26, 2025· Medline Industries, LP

Recalled Item: Medline Kits containing B. Braun IV Administration Sets and Pump

The Issue: Medline kits contain B. Braun IV Administration Sets

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

Class II — Potential Health HazardOngoing
November 26, 2025· Medline Industries, LP

Recalled Item: Medline Kits containing B. Braun IV Administration Sets and Pump

The Issue: Medline kits contain B. Braun IV Administration Sets

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

Class II — Potential Health HazardOngoing
November 26, 2025· Medline Industries, LP

Recalled Item: Medline Kits containing B. Braun IV Administration Sets and Pump

The Issue: Medline kits contain B. Braun IV Administration Sets

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

Class II — Potential Health HazardOngoing
November 26, 2025· Medline Industries, LP

Recalled Item: Medline Kits containing B. Braun IV Administration Sets and Pump

The Issue: Medline kits contain B. Braun IV Administration Sets

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

Class II — Potential Health HazardOngoing
November 26, 2025· Medline Industries, LP

Recalled Item: Medline Kits containing B. Braun IV Administration Sets and Pump

The Issue: Medline kits contain B. Braun IV Administration Sets

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

Class II — Potential Health HazardOngoing
November 26, 2025· Medline Industries, LP

Recalled Item: Medline Kits containing B. Braun IV Administration Sets and Pump

The Issue: Medline kits contain B. Braun IV Administration Sets

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

Class II — Potential Health HazardOngoing
November 26, 2025· Medline Industries, LP

Recalled Item: Medline Kits containing B. Braun IV Administration Sets and Pump

The Issue: Medline kits contain B. Braun IV Administration Sets

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

Class II — Potential Health HazardOngoing
November 26, 2025· Medline Industries, LP

Recalled Item: Medline Kits containing B. Braun IV Administration Sets and Pump

The Issue: Medline kits contain B. Braun IV Administration Sets

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

Class II — Potential Health HazardOngoing
November 26, 2025· Beckman Coulter, Inc.

Recalled Item: Beckman Coulter UniCel Dxl 600

The Issue: Beckman Coulter has determined that, due to a

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

Class II — Potential Health HazardOngoing
November 26, 2025· Beckman Coulter, Inc.

Recalled Item: Beckman Coulter UniCel Dxl 800

The Issue: Beckman Coulter has determined that, due to a

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

Class II — Potential Health HazardOngoing
November 26, 2025· Remote Diagnostic Technologies Ltd.

Recalled Item: Philips Tempus Pro Patient Monitor

The Issue: Patient monitor measures Intracranial Pressure (ICP) and Bladder

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

Class II — Potential Health HazardOngoing
November 26, 2025· Cook Incorporated

Recalled Item: Flexor Check-Flo Introducers and Sets

The Issue: Cook Medical identified that products supplied in the

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

Class II — Potential Health HazardOngoing
November 26, 2025· Cook Incorporated

Recalled Item: R¿sch-Uchida Transjugular Liver Access Sets

The Issue: Cook Medical identified that products supplied in the

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

Class II — Potential Health HazardOngoing
November 26, 2025· Cook Incorporated

Recalled Item: Ring Transjugular Intrahepatic Access Sets

The Issue: Cook Medical identified that products supplied in the

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

Class II — Potential Health HazardOngoing
November 25, 2025· Ferndale Laboratories, Inc.

Recalled Item: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog

The Issue: Butyrate tube cracks during actuation, rendering product unusable

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

Class II — Potential Health HazardOngoing
November 24, 2025· Abbott Diabetes Care, Inc.

Recalled Item: FreeStyle Libre 3 Sensor UDI-DI code: 00357599818005 The

The Issue: Due to a manufacturing process issue that may

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

Class I — Serious Health HazardOngoing
November 24, 2025· Abbott Diabetes Care, Inc.

Recalled Item: FreeStyle Libre 3 Plus Sensor UDI-DI code: 00357599844011

The Issue: Due to a manufacturing process issue that may

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

Class I — Serious Health HazardOngoing
November 24, 2025· Abbott Diabetes Care, Inc.

Recalled Item: FreeStyle Libre 3 Plus Sensor UDI-DI code: 00357599843014

The Issue: Due to a manufacturing process issue that may

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

Class I — Serious Health HazardOngoing