Cook Biotech, Inc.
FDA adverse event reports naming Cook Biotech, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: COOK BIOTECH, INC..
- Total reports
- 3,190
- Deaths
- 1
- Injuries
- 3,183
- Malfunctions
- 3
Reports per year
Source: FDA adverse event reports by year received, 2001–2024. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Mesh, SurgicalFTM2,283
- Mesh, Surgical, PolymericFTL588
- Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or TransobturatorPAG213
- Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally PlacedPAJ68
- Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or TransobturatorOTN14
- Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally PlacedOTP10
- Dura SubstituteGXQ6
- Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally PlacedPAI5
- Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally PlacedOTO2
- Patch, Pledget And Intracardiac, Petp, Ptfe, PolypropyleneDXZ1
Recent recalls
- 2025-01-10Open, ClassifiedUnder Investigation by firm
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.
- 2025-01-10Open, ClassifiedUnder Investigation by firm
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.
- 2025-01-10Open, ClassifiedUnder Investigation by firm
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.
- 2024-09-25Open, ClassifiedIncorrect or no expiration date
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
- 2024-09-25Open, ClassifiedIncorrect or no expiration date
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
- 2024-09-25Open, ClassifiedIncorrect or no expiration date
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
- 2024-09-25Open, ClassifiedIncorrect or no expiration date
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
- 2024-09-25Open, ClassifiedIncorrect or no expiration date
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
- 2024-09-25Open, ClassifiedIncorrect or no expiration date
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
- 2024-09-25Open, ClassifiedIncorrect or no expiration date
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
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