Cook recalls

Cook has 264 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 29 Dec 2021. 1 is still ongoing. The most frequent reason is sterility.

Total recalls264since 2013

Last 12 months0reported

Class I4216% of total

Ongoing1latest 29 Dec 2021

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 42 16%Class II 222 84%Class III 0 0%

Why cook is recalled

Product types

By year

202183%
20205420%
20199335%
20185119%
2017228%
2016259%
201583%
201410%
201321%

Ongoing cook recalls

1 active

Reported	Class	Recall	Company	Reason	Where
29 Dec 2021Device	CLASS II	Skinny Needle with Chiba Tip recalled by Cook	Cook	Other	Nationwide

All cook recalls, newest first

264 total

Reported	Class	Recall	Company	Reason	Where
29 Dec 2021Device	CLASS II	Skinny Needle with Chiba Tip recalled by Cook	Cook	Other	Nationwide
22 Dec 2021Device	CLASS II	Flexor Check-Flo Introducer Ansel Modification recalled by Cook	Cook	Labeling Errors	14 states
22 Dec 2021Device	CLASS II	Flexor Check-Flo Introducer Ansel Modification recalled by Cook	Cook	Labeling Errors	14 states
24 Nov 2021Device	CLASS II	Transseptal Needle, Trocar recalled by Cook	Cook	Device Malfunction	Nationwide
24 Nov 2021Device	CLASS II	Transseptal Needle with Catheter recalled by Cook	Cook	Foreign Material	Nationwide
10 Nov 2021Device	CLASS II	Flexor Check-Flo Introducer, Introducer Set recalled by Cook	Cook	Device Malfunction	15 states
10 Nov 2021Device	CLASS II	Flexor Check-Flo Introducer - Raabe Modification recalled by Cook	Cook	Device Malfunction	15 states
17 Feb 2021Device	CLASS II	Medical Kwart Retro-Inject Ureteral Stent Set recalled by Cook	Cook	Lead & Heavy Metals	6 states
30 Dec 2020Device	CLASS I	Flexor Check-Flo Introducer, RPN Kcfw-5.0-35-55-RB-HFANL0-HC recalled	Cook	Other	Nationwide
30 Dec 2020Device	CLASS I	Flexor Check-Flo Introducer, RPN Kcfw-4.0-35-55-RB-HFANL1-HC recalled	Cook	Other	Nationwide

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.