Cook Medical Biodesign Otologic Butterfly Graft — Class II medical device recall Z-0832-2025
Ongoing recall by Cook Biotech, Inc., reported 2025-01-22, distributed in IN, MI. Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two o
| Recall number | Z-0832-2025 |
|---|---|
| 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 | 2024-11-22 |
| Classified | 2025-01-10 |
| Reported by FDA | 2025-01-22 |
| Distributed | IN, MI |
| Countries outside the US | CA, KR |
| Quantity | 49 devices |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00827002602854, 10827002602851 |
| Lot numbers | LB1576761, LB1577308 |
| Model numbers | ENT-OTO-BFLY-0.4-0.6, G60285 |
| Expiration dates | 2025-01-21 |
Product
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Reason for recall
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
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-0832-2025. 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.