Class II — Potential Health Hazard

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

Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Recalled by Lumenis Ltd Due to Lumenis Ltd Announces a Field Action of the...

Date: November 17, 2015
Company: Lumenis Ltd
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 Lumenis Ltd directly.

Affected Products

Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).

Quantity: 33 filters

Why Was This Recalled?

Lumenis Ltd Announces a Field Action of the M22 IPL Acne Filters for the Lumenis M22 IPL Hand Piece due to the Risk of Superficial Burns When Using the Device.

Where Was This Sold?

This product was distributed to 12 states: CA, CO, CT, GA, KY, LA, MA, MN, NJ, NY, RI, SC

Affected (12 states)Not affected

About Lumenis Ltd

Lumenis Ltd has 1 total recall tracked by RecallDetector.

Related Recalls

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