--- title: "Cook Biotech, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Cook Biotech, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/cook-biotech-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Cook Biotech, Inc. recall records **15** reported ongoing 15 records in this archive. Latest source date Nov 22, 2024. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Nov 22, 2024 FDA device enforcement ### [Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.](https://isitonrecall.com/recall/fda-device-z-0832-2025-cook-medical-biodesign-otologic-butterfly-graft-ref-ent-oto-bfly-0-4-0-6-ref-g60285-sterile/) Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. Class II Reported ongoing Distribution: US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea. [Official source for Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0832-2025%22) Nov 22, 2024 FDA device enforcement ### [Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and](https://isitonrecall.com/recall/fda-device-z-0833-2025-cook-medical-biodesign-hiatal-hernia-graft-ref-c-phr-7x10-u-ref-g31455-sterile-and/) Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. Class II Reported ongoing Distribution: US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea. [Official source for Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0833-2025%22) Nov 22, 2024 FDA device enforcement ### [Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile](https://isitonrecall.com/recall/fda-device-z-0834-2025-cook-medical-biodesign-dural-graft-ref-c-dur-7x10-ref-g31091-sterile/) Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. Class II Reported ongoing Distribution: US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea. [Official source for Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0834-2025%22) Aug 7, 2024 FDA device enforcement ### [Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24667](https://isitonrecall.com/recall/fda-device-z-3250-2024-biodesign-fistula-plug-c-fpb-0-4-for-implantation-to-reinforce-soft-tissue-for-repair-of-recto-vagin/) Products expire prior to the expiration date printed on the product labeling Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, S... [Official source for Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3250-2024%22) Aug 7, 2024 FDA device enforcement ### [Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668](https://isitonrecall.com/recall/fda-device-z-3251-2024-biodesign-fistula-plug-c-fpb-0-7-for-implantation-to-reinforce-soft-tissue-for-repair-of-recto-vagin/) Products expire prior to the expiration date printed on the product labeling Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, S... [Official source for Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3251-2024%22) Aug 7, 2024 FDA device enforcement ### [Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54612](https://isitonrecall.com/recall/fda-device-z-3252-2024-biodesign-fistula-plug-c-fps-0-2-for-implantation-to-reinforce-soft-tissue-for-repair-of-recto-vagin/) Products expire prior to the expiration date printed on the product labeling Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, S... [Official source for Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3252-2024%22) Aug 7, 2024 FDA device enforcement ### [Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54613](https://isitonrecall.com/recall/fda-device-z-3253-2024-biodesign-fistula-plug-c-fps-0-4-for-implantation-to-reinforce-soft-tissue-for-repair-of-recto-vagin/) Products expire prior to the expiration date printed on the product labeling Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, S... [Official source for Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3253-2024%22) Aug 7, 2024 FDA device enforcement ### [Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54614](https://isitonrecall.com/recall/fda-device-z-3254-2024-biodesign-fistula-plug-c-fps-0-7-for-implantation-to-reinforce-soft-tissue-for-repair-of-recto-vagin/) Products expire prior to the expiration date printed on the product labeling Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, S... [Official source for Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3254-2024%22) Aug 7, 2024 FDA device enforcement ### [Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46374](https://isitonrecall.com/recall/fda-device-z-3255-2024-biodesign-fistula-plug-c-fps-0-2-2-for-implantation-to-reinforce-soft-tissue-for-repair-of-recto-vag/) Products expire prior to the expiration date printed on the product labeling Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, S... [Official source for Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of rect...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3255-2024%22) Aug 7, 2024 FDA device enforcement ### [Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372](https://isitonrecall.com/recall/fda-device-z-3256-2024-biodesign-fistula-plug-c-fps-0-4-2-for-implantation-to-reinforce-soft-tissue-for-repair-of-recto-vag/) Products expire prior to the expiration date printed on the product labeling Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, S... [Official source for Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of rect...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3256-2024%22) Aug 7, 2024 FDA device enforcement ### [Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46373](https://isitonrecall.com/recall/fda-device-z-3257-2024-biodesign-fistula-plug-c-fps-0-7-2-for-implantation-to-reinforce-soft-tissue-for-repair-of-recto-vag/) Products expire prior to the expiration date printed on the product labeling Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, S... [Official source for Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of rect...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3257-2024%22) Aug 7, 2024 FDA device enforcement ### [Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46601](https://isitonrecall.com/recall/fda-device-z-3258-2024-biodesign-recto-vaginal-fistula-plug-rvp-0-2-for-implantation-to-reinforce-soft-tissue-for-repair-of/) Products expire prior to the expiration date printed on the product labeling Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, S... [Official source for Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repa...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3258-2024%22) Aug 7, 2024 FDA device enforcement ### [Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602](https://isitonrecall.com/recall/fda-device-z-3259-2024-biodesign-recto-vaginal-fistula-plug-rvp-0-4-for-implantation-to-reinforce-soft-tissue-for-repair-of/) Products expire prior to the expiration date printed on the product labeling Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, S... [Official source for Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repa...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3259-2024%22) Aug 7, 2024 FDA device enforcement ### [Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46603](https://isitonrecall.com/recall/fda-device-z-3260-2024-biodesign-recto-vaginal-fistula-plug-rvp-0-7-for-implantation-to-reinforce-soft-tissue-for-repair-of/) Products expire prior to the expiration date printed on the product labeling Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, S... [Official source for Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repa...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3260-2024%22) Aug 7, 2024 FDA device enforcement ### [Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603](https://isitonrecall.com/recall/fda-device-z-3261-2024-biodesign-inguinal-hernia-graft-c-ihm-10x15-to-reinforce-soft-tissues-in-the-inguinal-floor-to-repai/) Products expire prior to the expiration date printed on the product labeling Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, S... [Official source for Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3261-2024%22) ## Reasons in these listed records - Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. - Products expire prior to the expiration date printed on the product labeling These examples come from this result page and are not a ranking of every recall reason. ## Checking Cook Biotech, Inc. ### Is there a recall on cook biotech, inc. right now? This archive contains 15 records, including 15 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Cook Biotech, Inc.](https://isitonrecall.com/check/?q=Cook%20Biotech%2C%20Inc.) 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