---
title: "Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, RE... — FDA record Z-0832-2025 | Is It on Recall"
description: "Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products."
url: https://isitonrecall.com/recall/fda-device-z-0832-2025-cook-medical-biodesign-otologic-butterfly-graft-ref-ent-oto-bfly-0-4-0-6-ref-g60285-sterile/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

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

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 22, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
- **Reason**: Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
- **Classification**: Class II
- **Recalling firm**: Cook Biotech, Inc.
- **Quantity**: 49 devices
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0832-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0832-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot #LB1576761, exp. 1/21/2025; and Lot #LB1577308, exp. 1/21/2025; Box UDI-DI 10827002602851, Pouch UDI-DI 00827002602854. |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Michigan](https://isitonrecall.com/state/michigan/)

## Dates in the source

- **Report date**: Jan 22, 2025
- **Recall initiation date**: Nov 22, 2024
- **Center classification date**: Jan 10, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0832-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Cook Biotech, Inc. records](https://isitonrecall.com/brand/cook-biotech-inc/)