FDA Medical Device Recalls (openFDA)
Cook Biotech, Inc.: Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
- Recall number
- Z-0832-2025
- Recalling firm
- Cook Biotech, Inc.
- Product
- Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
- Status
- Open, Classified
- Initiated
- 2024-11-22
- Posted
- 2025-01-10
- Terminated
- not on file
- Reason
- Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 49 devices
- Distribution
- US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.
- Lot, serial or model codes
- Lot #LB1576761, exp. 1/21/2025; and Lot #LB1577308, exp. 1/21/2025; Box UDI-DI 10827002602851, Pouch UDI-DI 00827002602854.
- 510(k) numbers
- ["K232646"]
- PMA numbers
- not on file
- Product code
- KHJ
- Firm FEI
- 3002340648
- Firm city
- W Lafayette
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28