Class II — Potential Health Hazard

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

Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Recalled by TERRAGENE S.A. Due to Due to a discrepancy between the FDA-Cleared Indications...

Date: December 7, 2023
Company: TERRAGENE S.A.
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 TERRAGENE S.A. directly.

Affected Products

Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Terragene Integron (PCD26-C) Terragene Bionova PCD (PCD222-C)

Quantity: 36,857 strips

Why Was This Recalled?

Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About TERRAGENE S.A.

TERRAGENE S.A. has 3 total recalls tracked by RecallDetector.

Related Recalls

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