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 14221–14240 of 38,428 recalls

September 4, 2020· Biomet, Inc.

Recalled Item: Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050

The Issue: Product not properly being aligned with the adequate

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

Class II — Potential Health HazardTerminated
September 3, 2020· Allison Medical, Inc.

Recalled Item: CarePoint 60 mL Syringe Without Needle

The Issue: Syringe without needle may have a green substance

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

Class II — Potential Health HazardCompleted
September 3, 2020· Biomet, Inc.

Recalled Item: (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup

The Issue: Zimmer Biomet is conducting a medical device recall

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

Class II — Potential Health HazardTerminated
September 2, 2020· Biomet, Inc.

Recalled Item: Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper...

The Issue: Product potentially being packaged without a taper adapter

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

Class II — Potential Health HazardTerminated
September 2, 2020· Gentian AS

Recalled Item: GENTIAN Cystatin C Calibrator and Calibrator Kit

The Issue: The firm has identified lots of calibrators that

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

Class II — Potential Health HazardTerminated
September 1, 2020· Fresenius Medical Care Holdings, Inc.

Recalled Item: AquaBplus and AquaBplus B2 Water Purification System. For use with

The Issue: Incorrectly crimped connectors were installed on the main

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

Class II — Potential Health HazardTerminated
September 1, 2020· Medline Industries Inc

Recalled Item: ClearPro Closed Suction Catheter

The Issue: There have been reports of the suction catheter

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

Class II — Potential Health HazardTerminated
August 31, 2020· ICU Medical, Inc.

Recalled Item: 30" (76 cm) Appx 3.3 ml

The Issue: for spinning versions of male luers to

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

Class II — Potential Health HazardOngoing
August 31, 2020· ICU Medical, Inc.

Recalled Item: 26 IN(66 cm) APPX 3.4ml

The Issue: for spinning versions of male luers to

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

Class II — Potential Health HazardOngoing
August 31, 2020· ICU Medical, Inc.

Recalled Item: 42 IN (107 cm) Appx 5.0 ml

The Issue: for spinning versions of male luers to

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

Class II — Potential Health HazardOngoing
August 31, 2020· ICU Medical, Inc.

Recalled Item: Spiros CLOSED MALE LUER w/RED CAP

The Issue: for spinning versions of male luers to

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

Class II — Potential Health HazardOngoing
August 31, 2020· ICU Medical, Inc.

Recalled Item: 30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber

The Issue: for spinning versions of male luers to

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

Class II — Potential Health HazardOngoing
August 31, 2020· ICU Medical, Inc.

Recalled Item: 5 IN (13 cm) Appx 1.5 ml

The Issue: for spinning versions of male luers to

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

Class II — Potential Health HazardOngoing
August 31, 2020· ICU Medical, Inc.

Recalled Item: Appx 1.7 ml Bag Spike w/Integrated Clave

The Issue: for spinning versions of male luers to

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

Class II — Potential Health HazardOngoing
August 31, 2020· ICU Medical, Inc.

Recalled Item: 76 cm (30") Appx 3.3 ml

The Issue: for spinning versions of male luers to

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

Class II — Potential Health HazardOngoing
August 31, 2020· ICU Medical, Inc.

Recalled Item: 30" (76 cm) Appx 3.2 ml

The Issue: for spinning versions of male luers to

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

Class II — Potential Health HazardOngoing
August 31, 2020· ICU Medical, Inc.

Recalled Item: Spinning Spiros Closed Male Luer

The Issue: for spinning versions of male luers to

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

Class II — Potential Health HazardOngoing
August 31, 2020· ICU Medical, Inc.

Recalled Item: 31" (78 cm) Appx 3.4 ml

The Issue: for spinning versions of male luers to

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

Class II — Potential Health HazardOngoing
August 31, 2020· ICU Medical, Inc.

Recalled Item: 3mL Syringe w/Spinning Spiros

The Issue: for spinning versions of male luers to

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

Class II — Potential Health HazardOngoing
August 31, 2020· ICU Medical, Inc.

Recalled Item: Spinning Spiros

The Issue: for spinning versions of male luers to

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

Class II — Potential Health HazardOngoing