Cook Biotech, Inc. has recalled approximately 65 Biodesign Surgical Grafts, including Otologic Butterfly, Hiatal Hernia, and Dural grafts, because they were shipped with an outdated version of the Instructions for Use (IFU) and incorrect expiration dates on some packaging. While no injuries have been reported, using these sterile grafts without updated instructions or past their actual shelf life could lead to improper surgical application. These medical devices were distributed to hospitals, surgical centers, and distributors in Indiana, Michigan, Canada, and South Korea.
The use of an incorrect instruction manual may lead to errors during surgery, while incorrect expiration dates could result in the use of a device that is no longer sterile or structurally sound. This poses a moderate risk of surgical complications or the need for follow-up procedures if the graft does not perform as expected.
Clinical/Hospital device correction or return.
Includes Box UDI-DI 10827002602851 and Pouch UDI-DI 00827002602854.
Includes Box UDI-DI 10827002314556 and Pouch UDI-DI 00827002314559.
Includes Box UDI-DI 10827002310916 and Pouch UDI-DI 00827002310919.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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