Cook Biotech, Inc. Recalls

15 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (15)

November 22, 2024
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
November 22, 2024
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
November 22, 2024
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
August 7, 2024
Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603
Products expire prior to the expiration date printed on the product labeling
Class II
August 7, 2024
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
Products expire prior to the expiration date printed on the product labeling
Class II
August 7, 2024
Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602
Products expire prior to the expiration date printed on the product labeling
Class II
August 7, 2024
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
Products expire prior to the expiration date printed on the product labeling
Class II
August 7, 2024
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
Products expire prior to the expiration date printed on the product labeling
Class II
August 7, 2024
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
Products expire prior to the expiration date printed on the product labeling
Class II
August 7, 2024
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
Products expire prior to the expiration date printed on the product labeling
Class II
August 7, 2024
Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46601
Products expire prior to the expiration date printed on the product labeling
Class II
August 7, 2024
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
Products expire prior to the expiration date printed on the product labeling
Class II
August 7, 2024
Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46603
Products expire prior to the expiration date printed on the product labeling
Class II
August 7, 2024
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
Products expire prior to the expiration date printed on the product labeling
Class II
August 7, 2024
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
Products expire prior to the expiration date printed on the product labeling
Class II

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