Cook Biotech, Inc. Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Brand
Cook Biotech, Inc.
Lot Codes / Batch Numbers
Lot #LB1576761, exp. 1/21/2025, and Lot #LB1577308, exp. 1/21/2025, Box UDI-DI 10827002602851, Pouch UDI-DI 00827002602854.
Products Sold
Lot #LB1576761, exp. 1/21/2025; and Lot #LB1577308, exp. 1/21/2025; Box UDI-DI 10827002602851, Pouch UDI-DI 00827002602854.
Cook Biotech, Inc. is recalling Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile. due to Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Recommended Action
Per FDA guidance
The recalling firm issued two different emails on 11/22/2024, one informing the direct account that the devices either had an incorrect IFU revision (Biodesign Otologic Butterfly Graft, ENT-OTO-BFLY-0.4-0.6) or had an incorrect expiration date (Biodesign Hiatal Hernia Graft, C-PHR, and Biodesign Dural Graft, C-DUR); and the other informing a different direct account that the product had an incorrect IFU revision for two lots (for Biodesign Otologic Butterfly Graft, ENT-OTO-BFLY-0.4-0.6). The direct accounts informed the recalling firm, and the recalling firm issued "URGENT: MEDICAL DEVICE RECALL" letters to its customers dated 12/10/2024. The letters instructed the customers to examine inventory and quarantine affected product, return the products to Cook Biotech Inc with a copy of a completed "Acknowledge and Receipt Form even if you do not have affected product(s) on hand; share notice and immediately report adverse events to Cook Biotech by phone 765-807-7888 or by email to: biotech.feedback@rtix.com. If you have any questions or concerns, please contact Cook Biotech at 765-807-7888.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticeDistribution
As reported by FDA
IN, MI
Page updated: Jan 10, 2026
Important Notice
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