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 | Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. |
| Product | Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile |
| Quantity | 10 devices |
| Distribution | US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea. |
| Initiated | 2024-11-22 |
| Classified | 2025-01-10 |
| Recall number | Z-0834-2025 |
| 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-0834-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95961/
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