Recall archive / FDA device enforcement
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile. — FDA record Z-0832-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 22, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
- Reason
- Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
- Classification
- Class II
- Recalling firm
- Cook Biotech, Inc.
- Quantity
- 49 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0832-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot #LB1576761, exp. 1/21/2025; and Lot #LB1577308, exp. 1/21/2025; Box UDI-DI 10827002602851, Pouch UDI-DI 00827002602854. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 22, 2025
- Recall initiation date
- Nov 22, 2024
- Center classification date
- Jan 10, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.