Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Recalled by Integra Limited Due to Stability did not meet acceptance criteria for visual...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Integra Limited directly.
Affected Products
Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor sites/grafts, post-Moh s surgery, post-laser surgery, podiatric, wound dehiscence) and diabetic ulcers of both partial and full-thickness varieties. The device is intended for one-time use.
Quantity: 274 units
Why Was This Recalled?
Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Integra Limited
Integra Limited has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report