Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PriMatrix Fenestrated Recalled by TEI Biosciences, Inc. Due to Possible out of specification endotoxin test results due...
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 TEI Biosciences, Inc. directly.
Affected Products
PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).
Quantity: 30,528 units
Why Was This Recalled?
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About TEI Biosciences, Inc.
TEI Biosciences, Inc. has 17 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report