Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SurgiMend PRS 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 PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, 10x15 cm Slant Fenestrated, 7x17 cm Semi-Oval, 8x16 cm Thin Semi-Oval, 10x20 cm Thin Semi-Oval, 6x16 cm Semi-Oval, Thin Oval 8x12 cm, Thin Oval 10x15 cm, Meshed 20cm x 10cm
Quantity: 22,163 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