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Cook Biotech, Inc. FDA Recalls

15 recalls on file across devices, 0 of them Class I and 15 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.Class IINov 22, 2024Incorrect version of IFU was used rather than updated versio	Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two o	Class IIDevices	Nov 22, 2024
Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; andClass IINov 22, 2024Incorrect version of IFU was used rather than updated versio	Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two o	Class IIDevices	Nov 22, 2024
Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, SterileClass IINov 22, 2024Incorrect version of IFU was used rather than updated versio	Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two o	Class IIDevices	Nov 22, 2024
Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal herniasClass IIAug 7, 2024Products expire prior to the expiration date printed on the	Products expire prior to the expiration date printed on the product labeling	Class IIDevices	Aug 7, 2024
Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal Class IIAug 7, 2024Products expire prior to the expiration date printed on the	Products expire prior to the expiration date printed on the product labeling	Class IIDevices	Aug 7, 2024
Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fisClass IIAug 7, 2024Products expire prior to the expiration date printed on the	Products expire prior to the expiration date printed on the product labeling	Class IIDevices	Aug 7, 2024
Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fiClass IIAug 7, 2024Products expire prior to the expiration date printed on the	Products expire prior to the expiration date printed on the product labeling	Class IIDevices	Aug 7, 2024
Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal Class IIAug 7, 2024Products expire prior to the expiration date printed on the	Products expire prior to the expiration date printed on the product labeling	Class IIDevices	Aug 7, 2024
Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal Class IIAug 7, 2024Products expire prior to the expiration date printed on the	Products expire prior to the expiration date printed on the product labeling	Class IIDevices	Aug 7, 2024
Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fisClass IIAug 7, 2024Products expire prior to the expiration date printed on the	Products expire prior to the expiration date printed on the product labeling	Class IIDevices	Aug 7, 2024
Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fiClass IIAug 7, 2024Products expire prior to the expiration date printed on the	Products expire prior to the expiration date printed on the product labeling	Class IIDevices	Aug 7, 2024
Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fisClass IIAug 7, 2024Products expire prior to the expiration date printed on the	Products expire prior to the expiration date printed on the product labeling	Class IIDevices	Aug 7, 2024
Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fiClass IIAug 7, 2024Products expire prior to the expiration date printed on the	Products expire prior to the expiration date printed on the product labeling	Class IIDevices	Aug 7, 2024
Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fiClass IIAug 7, 2024Products expire prior to the expiration date printed on the	Products expire prior to the expiration date printed on the product labeling	Class IIDevices	Aug 7, 2024
Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fiClass IIAug 7, 2024Products expire prior to the expiration date printed on the	Products expire prior to the expiration date printed on the product labeling	Class IIDevices	Aug 7, 2024

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