TEI Biosciences recalls Revize-X collagen matrix for soft tissue reconstruction due to potential endotoxin test failures in manufacturing. This is a prescription-only product with specific sizes.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
TEI Biosciences is recalling Revize-X collagen matrix products for soft tissue reconstruction because of possible endotoxin test failures during manufacturing. This affects prescription-only products with specific sizes and requires attention to ensure safety.
The recall is due to possible out of specification endotoxin test results in the manufacturing process. Endotoxins are bacterial components that can cause serious infections if present in medical products. This issue may arise from problems with testing in-process and finished goods.
Prescription-only users of Revize-X collagen matrix products for soft tissue reconstruction. Patients using the specific sizes (12x6 cm and 10x9 cm) are most at risk.
Check for the product name 'Revize-X' and sizes 12x6 cm or 10x9 cm. The unique identifiers are 611-005-001 (10381780357308) and 611-005-002 (10381780357315).
Verify the product size and unique identifiers to confirm if it is recalled.
The recall indicates possible endotoxin test failures, but the official notice does not specify if the product is safe to use.
The recall record does not provide a remedy or specific action steps for affected users.
Check for the product name 'Revize-X', sizes 12x6 cm or 10x9 cm, and unique identifiers 611-005-001 (10381780357308) or 611-005-002 (10381780357315).
We’ve drafted a message you can send TEI Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2084-2023 — TEI Biosciences TEI Biosciences Hello, I own a TEI Biosciences that is covered by recall Z-2084-2023 from TEI Biosciences. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
