Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix Recalled by Integra LifeSciences Corporation Due to Due to the process deviation, product lots in...
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 LifeSciences Corporation directly.
Affected Products
DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
Quantity: 21,179 boxes
Why Was This Recalled?
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Integra LifeSciences Corporation
Integra LifeSciences Corporation has 29 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report