TEI Biosciences TissueMend Matrix: Possible Endotoxin Test Issues

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Contact the company & request your remedy

Recalling firmTEI Biosciences, Inc.7 Elkins St, N/A · Boston, MA 02127-1601

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

TEI Biosciences is recalling their TissueMend Advanced Soft Tissue Repair Matrix products for possible endotoxin test failures. This could affect medical use if the product doesn't meet safety standards.

Why it’s dangerous

The recall is due to possible issues with endotoxin testing during production. Endotoxins are harmful substances that can cause infections or adverse reactions if present in medical products.

Who’s affected

Medical professionals and patients using the TissueMend matrix for soft tissue repair may be affected. Those with the specific sizes (5x6 cm, 6x10 cm, 3x3 cm) are most at risk.

How to tell if you have this one

Check for the product names TissueMend Advanced Soft Tissue Repair Matrix (Rx Only) with sizes 5x6 cm, 6x10 cm, or 3x3 cm. The unique identifiers include 6495-9-001 (10381780113621), 6495-9-004 (10381780113638), and 6495-9-006 (10381780113645).

Brand
TEI Biosciences
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product size and unique identifiers to confirm if it is affected.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The recall is due to possible out of specification endotoxin test results, which could affect medical safety.

What sizes of TissueMend are affected?

Sizes 5x6 cm, 6x10 cm, and 3x3 cm are affected.

Is there a remedy for this recall?

The recall notice does not specify a remedy.

Take action

Contact TEI Biosciences

We’ve drafted a message you can send TEI Biosciences to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2085-2023 — TEI Biosciences TEI Biosciences

Hello,

I own a TEI Biosciences that is covered by recall Z-2085-2023 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.

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Where this comes from

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.

Official source: FDA Recall #Z-2085-2023 (May 23, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2085-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

TEI Biosciences, Inc. recalls TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm.

Recall notice