TEI Biosciences, Inc. is recalling approximately 164,175 units of various collagen matrices and dermal repair scaffolds, including SurgiMend, PriMatrix, Revize, and TissueMend brands. These surgical products are being recalled because they may have failed endotoxin testing (a test for certain bacterial toxins) due to issues with the testing process for both in-process materials and finished goods. This voluntary recall affects dozens of product sizes and configurations used in soft tissue reconstruction and dermal repair.
The presence of endotoxins above specific safety levels can cause an inflammatory response, fever, or other systemic reactions in patients after surgery. While no specific injuries were mentioned in this report, out-of-specification results for these toxins pose a moderate risk of post-operative complications.
Quarantine and Return
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.
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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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