Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0832-2025 — Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.

U.S. FDA — Device Enforcement · United States · 2024-11-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0832-2025
Date of alert
2024-11-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Cook Biotech, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10827002602851
Reported risk: Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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