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 14601–14620 of 38,428 recalls

July 6, 2020· ICU Medical, Inc.

Recalled Item: 114" (290 cm) 60 Drop 150ml Burette Set (Clave

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: 26 IN(66cm) APPX 3.9 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: DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold

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 0.26 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: 11 IN (28cm) APPX 1.5ml EXT SET NanoClave

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: 10 IN (25cm) APPX 1.1ml

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: 6.5" (17 cm) Appx 0.30 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: Clave Stopcock. 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: 5 IN(13cm) APPX 0.87ml

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) 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: 226 cm (89 IN) APPX 2.7ml

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: 58cm (23 IN) APPX 2.1 ml EXT SET Smallbore PUR Yellow w/6-Port Clave

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: 60 IN(152cm) APPX 0.85ml

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: 7.5" (19 cm) Appx 0.59 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: 99 IN (251cm) APPX 12.6ml

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" (23 cm) Appx 0.63 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: 9 IN(23 cm) Appx 0.89ml

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. 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: 20 IN(51cm) APPX 2.5ml

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: 78" (198 cm) APPX 1.7ml

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