Class II — Potential Health Hazard

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

SurgiMend PRS Meshed 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

SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm

Quantity: 9,215 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