Class II — Potential Health Hazard

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

Endoform Dermal Template 2x2 Recalled by AROA BIOSURGERY Due to Potential for pouch seal failure

Date: November 27, 2018
Company: AROA BIOSURGERY
Status: Terminated
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 AROA BIOSURGERY directly.

Affected Products

Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.

Quantity: 8,853 total boxes

Why Was This Recalled?

Potential for pouch seal failure

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About AROA BIOSURGERY

AROA BIOSURGERY has 3 total recalls tracked by RecallDetector.

Related Recalls

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