TEI Biosciences SurgiMend PRS Meshed Recall: Possible Endotoxin Test Issues

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

TEI Biosciences is recalling SurgiMend PRS Meshed collagen matrix for soft tissue reconstruction because of possible endotoxin test issues. This is a prescription-only product sold in Canada and Europe. The recall does not specify a remedy or how to check if you have the product.

Why it’s dangerous

The recall mentions possible out of specification endotoxin test results, which could mean the product contains harmful bacteria. Endotoxins are substances that can cause serious infections if they enter the body.

Who’s affected

Prescription patients in Canada and Europe who use SurgiMend PRS Meshed for soft tissue reconstruction are likely affected. Patients using the product without a prescription are not affected.

How to tell if you have this one

Check for the product name 'SurgiMend PRS Meshed' with size 10cm x 20cm. This prescription-only product was distributed in Canada and Europe.

Brand
TEI Biosciences
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the product name 'SurgiMend PRS Meshed' with size 10cm x 20cm.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall states possible endotoxin test issues, but does not confirm if the product is unsafe. The manufacturer has not provided a remedy.

Do I need to stop using this product?

The recall does not specify a remedy, so there is no instruction to stop using the product.

Where was this product sold?

This product was distributed in Canada and Europe.

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-2076-2023 — TEI Biosciences TEI Biosciences

Hello,

I own a TEI Biosciences that is covered by recall Z-2076-2023 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-2076-2023 (May 23, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2076-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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 SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm

Recall notice