Class II — Cook Biotech, Inc.
| Recalling firm | COOK BIOTECH, INC. |
|---|---|
| Registered facility | COOK BIOTECH, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Products expire prior to the expiration date printed on the product labeling |
| Product | 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 |
| Quantity | 93 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, South Africa, United Kingdom. |
| Initiated | 2024-08-07 |
| Classified | 2024-09-25 |
| Recall number | Z-3253-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cook Biotech, Inc. (Z-3253-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95149/
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