Cook Biotech, Inc. is recalling 544 units of Biodesign Fistula Plugs and Inguinal Hernia Grafts because these medical implants may expire before the date printed on their labels. These devices are used in surgical procedures to reinforce soft tissue for the repair of hernias and various types of fistulas (abnormal connections between organs). Because the products may degrade or lose effectiveness earlier than expected, using them past their true shelf life could lead to surgical complications or the need for additional procedures. This recall affects various models of the Biodesign Fistula Plug and Inguinal Hernia Graft distributed worldwide, including 120 units of the Inguinal Hernia Graft and over 400 units of various fistula plug models.
The use of these implants beyond their actual expiration date may result in the material failing to properly reinforce tissue, potentially leading to the recurrence of the fistula or hernia, infection, or the need for follow-up surgery. While no specific injuries have been reported in this data, the integrity of the implanted material cannot be guaranteed once it has passed its actual expiration point.
Notification and guidance for healthcare providers
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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