Cook Biotech recalls

Cook Biotech has 15 recalls on record with the FDA and USDA, the earliest in 2024 and the latest reported on 22 Jan 2025. 15 are still ongoing.

Total recalls15since 2024

Last 12 months0reported

Class I00% of total

Ongoing15latest 22 Jan 2025

Recalls per month, last 24 months

click a bar for that month

12Oct '24 0 0 3Jan '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 0 0%Class II 15 100%Class III 0 0%

Why cook biotech is recalled

Other Reasons1280%
Sterility320%

Product types

Other Medical Devices15100%

By year

2025320%
20241280%

Ongoing cook biotech recalls

15 active

Reported	Class	Recall	Company	Reason	Where
22 Jan 2025Device	CLASS II	Cook Medical Biodesign Dural Graft recalled by Cook Biotech	Cook Biotech	Sterility	MI
22 Jan 2025Device	CLASS II	Cook Medical Biodesign Otologic Butterfly Graft recalled by Cook Biotech	Cook Biotech	Sterility	MI
22 Jan 2025Device	CLASS II	Cook Medical Biodesign Hiatal Hernia Graft recalled by Cook Biotech	Cook Biotech	Sterility	MI
2 Oct 2024Device	CLASS II	Biodesign Fistula Plug C-fps recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024Device	CLASS II	Biodesign Fistula Plug C-fps recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024Device	CLASS II	Biodesign Recto-Vaginal Fistula Plug RVP recalled by Cook Biotech	Cook Biotech	Other	Nationwide

All cook biotech recalls, newest first

15 total

Reported	Class	Recall	Company	Reason	Where
22 Jan 2025Device	CLASS II	Cook Medical Biodesign Dural Graft recalled by Cook Biotech	Cook Biotech	Sterility	MI
22 Jan 2025Device	CLASS II	Cook Medical Biodesign Otologic Butterfly Graft recalled by Cook Biotech	Cook Biotech	Sterility	MI
22 Jan 2025Device	CLASS II	Cook Medical Biodesign Hiatal Hernia Graft recalled by Cook Biotech	Cook Biotech	Sterility	MI
2 Oct 2024Device	CLASS II	Biodesign Fistula Plug C-fps recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024Device	CLASS II	Biodesign Fistula Plug C-fps recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024Device	CLASS II	Biodesign Recto-Vaginal Fistula Plug RVP recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024Device	CLASS II	Biodesign Fistula Plug C-fps recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024Device	CLASS II	Biodesign Fistula Plug C-fpb recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024Device	CLASS II	Biodesign Fistula Plug C-fps recalled by Cook Biotech	Cook Biotech	Other	Nationwide
2 Oct 2024Device	CLASS II	Biodesign Fistula Plug C-fps recalled by Cook Biotech	Cook Biotech	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.