Class II — Potential Health Hazard

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

PROKERA Plus Recalled by TissueTech, Inc. Due to Potential exposure of product to microbial contamination.

Date: November 10, 2020
Company: TissueTech, Inc.
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 TissueTech, Inc. directly.

Affected Products

PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.

Quantity: 10 units

Why Was This Recalled?

Potential exposure of product to microbial contamination.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About TissueTech, Inc.

TissueTech, Inc. has 3 total recalls tracked by RecallDetector.

Related Recalls

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