AROA BIOSURGERY Endoform Dermal Template 2x2 Recall: Pouch Seal Failure Risk

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Recalling firmAROA BIOSURGERY2 Kingsford Smith Place · Airport Oaks, N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

AROA BIOSURGERY is recalling Endoform Dermal Template 2x2 products due to a potential pouch seal failure. This could lead to the product not staying sterile or effective during medical use. Patients using this product should contact the manufacturer for guidance.

Why it’s dangerous

The pouch seal might fail, causing the product to lose sterility or effectiveness. This could lead to infection or improper wound healing if the product is not properly sealed during use.

Who’s affected

Patients using Endoform Dermal Template 2x2 for wound care are affected. Those with specific lot numbers (EDT-7I01, EDT-7K01, EDT-7L05) are most at risk.

How to tell if you have this one

Check for lot numbers EDT-7I01, EDT-7K01, or EDT-7L05 on the product packaging. The product is a sterile, single-use template for wound care.

Brand
AROA BIOSURGERY
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for lot numbers EDT-7I01, EDT-7K01, or EDT-7L05 on the packaging.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The product is safe for use if the pouch seal remains intact. However, the recall indicates a potential risk of seal failure.

What should I do if I have this product?

Contact AROA BIOSURGERY directly for instructions on next steps.

How can I tell if I have the recalled product?

Check for lot numbers EDT-7I01, EDT-7K01, or EDT-7L05 on the packaging.

Take action

Contact AROA BIOSURGERY

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

✉️ Open in email

Subject: Recall Z-0378-2019 — AROA BIOSURGERY AROA BIOSURGERY

Hello,

I own a AROA BIOSURGERY that is covered by recall Z-0378-2019 from AROA BIOSURGERY.

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-0378-2019 (November 27, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0378-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.

AROA BIOSURGERY recalls Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine

Lower-risk recall