Integra Flowable Wound Matrix recall: Stability issues during mixing and storage

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Contact the company & request your remedy

Recalling firmIntegra Limited311 Enterprise Dr · Plainsboro, NJ 08536-3344

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

✎ GovInfoNow plain-language explainer

What happened, in plain English

Integra is recalling Flowable Wound Matrix (FWD3: 2991332) because it may not stay stable during mixing and storage. This could affect wound healing effectiveness if the product degrades over time.

Why it’s dangerous

The product may change appearance or lose strength after mixing and storing for up to six months. This could reduce its effectiveness for wound healing.

Who’s affected

Patients using this wound dressing for tunneling or diabetic ulcers. Those with specific wound types like surgical wounds or post-laser injuries are most at risk.

How to tell if you have this one

Check for Catalog No: FWD301 on the product label. Affected lots include 2991332. The product is used for specific wound types like surgical wounds or diabetic ulcers.

Brand
Integra
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for Catalog No: FWD301 and Lot Code 2991332 on the product.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The product may not stay stable during mixing and storage, which could affect wound healing effectiveness.

What should I do if I have this product?

Check the product label for Catalog No: FWD301 and Lot Code 2991332. If it matches, contact Integra for guidance.

How long does the product last?

The product may not maintain proper appearance or strength after six months of storage.

Take action

Contact Integra

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

✉️ Open in email

Subject: Recall Z-1338-2019 — Integra Integra

Hello,

I own a Integra that is covered by recall Z-1338-2019 from Integra.

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-1338-2019 (March 31, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1338-2019 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.

Integra Limited recalls Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the

Lower-risk recall