Biodesign Fistula Plug C-FPB-0 — Class II medical device recall Z-3251-2024
Ongoing recall by Cook Biotech, Inc., reported 2024-10-02, distributed nationwide. Products expire prior to the expiration date printed on the product labeling
| Recall number | Z-3251-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Biotech, Inc., W Lafayette, IN, United States |
| Recall initiated | 2024-08-07 |
| Classified | 2024-09-25 |
| Reported by FDA | 2024-10-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CA, CN, DE, FI, FR, GB, IE, LU, NL, NO, NZ, ZA |
| Quantity | 3 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00827002246683 |
| Lot numbers | LB1536090, LB1536126 |
Product
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
Reason for recall
Products expire prior to the expiration date printed on the product labeling
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3251-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.