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 14641–14660 of 38,428 recalls

July 6, 2020· ICU Medical, Inc.

Recalled Item: NanoClave Connector. 1 unit per pouch

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: 12" (30 cm) Appx 0.67 ml

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: 165cm (65 IN)APPX 2.2ml

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: 120 IN (305cm)APPX 15.4ml

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: 139" (353 cm) 15 Drop Admin Set w/3 MicroClave Clear

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: 9.5" (24 cm) Appx 0.45 ml

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: 8 IN (20CM) APPX 1.3ml

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: 11 IN(28cm)APPX 0.7ml

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: 3-Port NanoClave Manifold w/Check Valve

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: 8 IN(20cm) APPX 0.46ml

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: 9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: 2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: NanoClave Connector

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: 135 cm (53") Ext Set w/Remv 5 Gang Stopcock

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: 8" (20 cm) Appx 0.53 ml

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: Appx 0.82 ml

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: 6" (15 cm) Appx 0.24 ml

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: 12 IN(30cm) APPX 2.1ml

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: 5" (13 cm) Appx 0.39 ml

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated
July 6, 2020· ICU Medical, Inc.

Recalled Item: APPX 0.75 ml

The Issue: Identification of a potential manufacturing defect on the

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

Class II — Potential Health HazardTerminated