Class II — Potential Health Hazard

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

XTRAC Excimer Laser Recalled by Strata Skin Sciences, Inc. Due to When the Liquid Guide ( LLG) is not...

Date: January 23, 2017
Company: Strata Skin Sciences, 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 Strata Skin Sciences, Inc. directly.

Affected Products

XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the skin conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma.

Quantity: US - 1000 , Foreign - 612

Why Was This Recalled?

When the Liquid Guide ( LLG) is not used according to the operator manual, the switch control wires may become loose and shorted. Shorted wires may lead to unintentional laser firing.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Strata Skin Sciences, Inc.

Strata Skin Sciences, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

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