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 14661–14680 of 38,428 recalls

July 6, 2020· ICU Medical, Inc.

Recalled Item: 109" (277 cm) Appx 8.6 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: 112 IN (284cm) APPX 14.7ml 15 DROP SET 2 MicroClave

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: 98 IN (249cm) APPX 8.4 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: 7 IN (18cm) APPX 1.2ml Ext Set w/6-Port NanoClave 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: 60" (152 cm) Appx 1.0 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: 47 IN (119cm) APPX 6.7 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: 142 IN (361cm) APPX 18.8 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: 6.5 IN (17 cm) APPX 0.78 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: 5.5" (14 cm) Appx 0.50 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: PROXIMALE

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 1.5ml

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: 29 IN (74 cm) 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: 113" (287 cm) Appx 14.7 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: 107" (272 cm) Appx 9.1 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" (20 cm) Appx 0.33 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: 78 IN (198cm) APPX 10.0 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: 123 IN (312cm) APPX 16.1 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: SURPLUG Nano 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: 124" (315 cm) 60 Drop 150 mL Burette Set (w/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: 148 IN (376cm) APPX 18.8 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