FDA Medical devices recall ·
Cook Medical Biodesign Otologic Butterfly Graft recall
- Recall number
- Z-0832-2025
- Date
- (initiated November 22, 2024)
- Company / brand
- Cook Biotech, Inc.
1425 Innovation Pl, W Lafayette, IN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 49 devices
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Why was it recalled?
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #LB1576761, exp. 1/21/2025; and Lot #LB1577308, exp. 1/21/2025; Box UDI-DI 10827002602851, Pouch UDI-DI 00827002602854.
Distribution
US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0832-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.