TEI Biosciences recalls SurgiMend 1.0 collagen matrix products due to possible endotoxin test failures. These Rx-only medical devices may pose risks if used improperly. Check item numbers for affected units.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
TEI Biosciences is recalling SurgiMend 1.0 collagen matrix products for soft tissue reconstruction. The recall is due to possible endotoxin test failures in manufacturing, which could affect safety if used improperly.
Endotoxins are harmful substances found in bacteria. If the endotoxin test results are out of specification, the product may contain unsafe levels that could cause infection or other complications when used in medical procedures.
Patients prescribed SurgiMend 1.0 by healthcare providers. Those using the product without a prescription or medical supervision are not affected.
Check for item numbers 606-005-003 (10381780112952) or 606-005-004 (10381780112969) on the product packaging. These are the specific units recalled by TEI Biosciences.
Look for item numbers 606-005-003 (10381780112952) or 606-005-004 (10381780112969) on the product packaging.
The recall is due to possible endotoxin test failures, but the product may still be safe if used correctly. TEI Biosciences has not provided specific instructions on whether to stop using it.
Check the product for the specific item numbers listed. If you have the recalled item numbers, contact TEI Biosciences for further instructions.
Look for item numbers 606-005-003 (10381780112952) or 606-005-004 (10381780112969) on the product packaging.
We’ve drafted a message you can send TEI Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2071-2023 — TEI Biosciences TEI Biosciences Hello, I own a TEI Biosciences that is covered by recall Z-2071-2023 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.
