Cook Biotech, Inc.
15 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Cook Biotech, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-01-22FDA-DeviceClass IICook 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.
- 2025-01-22FDA-DeviceClass IICook 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.
- 2025-01-22FDA-DeviceClass IICook 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.
- 2024-10-02FDA-DeviceClass IIBiodesign 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
- 2024-10-02FDA-DeviceClass IIBiodesign 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
- 2024-10-02FDA-DeviceClass IIBiodesign 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
- 2024-10-02FDA-DeviceClass IIBiodesign 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
- 2024-10-02FDA-DeviceClass IIBiodesign 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
- 2024-10-02FDA-DeviceClass IIBiodesign 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
- 2024-10-02FDA-DeviceClass IIBiodesign 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
- 2024-10-02FDA-DeviceClass IIBiodesign 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
- 2024-10-02FDA-DeviceClass IIBiodesign 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
- 2024-10-02FDA-DeviceClass IIBiodesign 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
- 2024-10-02FDA-DeviceClass IIBiodesign 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
- 2024-10-02FDA-DeviceClass IIBiodesign 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
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