Cook Medical Biodesign Hiatal Hernia Graft, REF… recallZ-0833-2025 · Cook Biotech, Inc. · initiated Nov 22, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cook Biotech, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
FDA root cause category: Under Investigation by firm
What the company is doing
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: [email protected]. If you have any questions or concerns, please contact Cook Biotech at 765-807-7888.
Recall details
- Recall number
- Z-0833-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 22, 2024
- Posted by the FDA
- Jan 10, 2025
- Recalling firm
- Cook Biotech, Inc.
- Quantity
- 6 devices
- Product code
- OWV
- FDA submissions
- K133011
- Distribution
- US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.
Product description
Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
Code information (models, lots, serial numbers)
Lot #LB1579758, exp. 2/19/2026; Box UDI-DI 10827002314556, Pouch UDI-DI 00827002314559.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Biodesign G31455Cook Biotech Incorporated · Mesh, surgical, collagen, diaphragmatic hernia1 recall1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 95961).
- Z-0832-2025 · Open, ClassifiedCook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
- Z-0834-2025 · Open, ClassifiedCook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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