Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SurgiMend 4.0 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
SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and 10x25 cm Fenestrated.
Quantity: 5,664 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