Cook Medical recalls specific Otologic Butterfly Graft products due to incorrect instructions and expiration dates used in manufacturing. Affected items have lot numbers LB1576761 and LB1577308 with expiration 1/21/2025. Consumers should contact Cook for details.
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Cook Medical is recalling certain Otologic Butterfly Graft products because incorrect instructions and expiration dates were used during manufacturing. This could lead to improper use if the wrong version of instructions or expiration date is followed.
The recall involves two products where the incorrect version of the instructions for use (IFU) was used instead of the updated version, and an incorrect expiration date was applied. This could lead to improper use if the wrong instructions or expiration date is followed.
Patients who received the specific Otologic Butterfly Graft products with lot numbers LB1576761 or LB1577308, expiring 1/21/2025, are most at risk. These products were used in ear surgeries.
Check for lot numbers LB1576761 or LB1577308 on the packaging, with an expiration date of 1/21/2025. The products are sterile and labeled as Cook Medical Biodesign Otologic Butterfly Graft.
Reach out to Cook Medical directly for specific instructions on how to handle the recalled products.
The recall is due to incorrect instructions for use (IFU) and an incorrect expiration date being used on two specific products during manufacturing.
Products with lot numbers LB1576761 and LB1577308, expiring 1/21/2025, are affected.
Look for lot numbers LB1576761 or LB1577308 on the packaging with an expiration date of 1/21/2025.
We’ve drafted a message you can send Cook Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0832-2025 — Cook Medical Cook Medical Hello, I own a Cook Medical that is covered by recall Z-0832-2025 from Cook Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
