Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

PriMatrix Ag Fenestrated Recalled by TEI Biosciences, Inc. Due to Possible out of specification endotoxin test results due...

Date: May 23, 2023
Company: TEI Biosciences, Inc.
Status: Ongoing
Source: FDA (Device)

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 Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.

Quantity: 7,264 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.

Affected (51 states)Not affected

About TEI Biosciences, Inc.

TEI Biosciences, Inc. has 17 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report