Cook Incorporated recalls

Cook Incorporated has 85 recalls on record with the FDA and USDA, the earliest in 2022 and the latest reported on 13 May 2026. 84 are still ongoing. 24 were reported in the last 12 months. The most frequent reason is sterility.

Total recalls85since 2022

Last 12 months24reported

Class I67% of total

Ongoing84latest 13 May 2026

Recalls per month, last 24 months

click a bar for that month

1Oct '24 3 0 0Jan '25 0 0 0Apr 3 1 0Jul 0 0 0Oct 0 3 0Jan '26 0 0 18Apr 3 0 0Jul 0 0

Severity split

Class I 6 7%Class II 79 93%Class III 0 0%

Why cook incorporated is recalled

Product types

By year

20262125%
202578%
20241416%
202322%
20224148%

Ongoing cook incorporated recalls

84 active

Reported	Class	Recall	Company	Reason	Where
13 May 2026Device	CLASS I	Beacon Tip Centimeter Sizing Catheter RPN/GPN recalled	Cook Incorporated	Sterility	Nationwide
13 May 2026Device	CLASS I	Aurous Centimeter Sizing Catheter RPN recalled by Cook Incorporated	Cook Incorporated	Sterility	Nationwide
13 May 2026Device	CLASS I	Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-Pig-csc recalled	Cook Incorporated	Device Malfunction	Nationwide
15 Apr 2026Device	CLASS II	Medical Cook Staged Extubation Set: Reference recalled	Cook Incorporated	Other	IN
15 Apr 2026Device	CLASS II	Medical Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference recalled	Cook Incorporated	Other	IN
15 Apr 2026Device	CLASS II	Medical Wayne Pneumothorax Tray: Reference recalled by Cook Incorporated	Cook Incorporated	Other	IN

All cook incorporated recalls, newest first

85 total

Reported	Class	Recall	Company	Reason	Where
13 May 2026Device	CLASS I	Beacon Tip Centimeter Sizing Catheter RPN/GPN recalled	Cook Incorporated	Sterility	Nationwide
13 May 2026Device	CLASS I	Aurous Centimeter Sizing Catheter RPN recalled by Cook Incorporated	Cook Incorporated	Sterility	Nationwide
13 May 2026Device	CLASS I	Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-Pig-csc recalled	Cook Incorporated	Device Malfunction	Nationwide
15 Apr 2026Device	CLASS II	Medical Cook Staged Extubation Set: Reference recalled	Cook Incorporated	Other	IN
15 Apr 2026Device	CLASS II	Medical Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference recalled	Cook Incorporated	Other	IN
15 Apr 2026Device	CLASS II	Medical Wayne Pneumothorax Tray: Reference recalled by Cook Incorporated	Cook Incorporated	Other	IN
15 Apr 2026Device	CLASS II	Medical Approach Cto-12 Micro Wire Guide: Reference recalled	Cook Incorporated	Other	IN
15 Apr 2026Device	CLASS II	Medical NCompass¿ Nitinol Stone Extractor: Reference recalled	Cook Incorporated	Other	IN
15 Apr 2026Device	CLASS II	Medical Ciaglia Blue Rhino Percutaneous Tracheostomy recalled	Cook Incorporated	Other	IN
15 Apr 2026Device	CLASS II	Medical Multipurpose Drainage Catheter: Reference recalled	Cook Incorporated	Other	IN

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.