Lumenis Ltd: Medical Device Recall in 2016 - (Recall #: Z-1669-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 17, 2015

Date Posted: May 25, 2016

Recall Number: Z-1669-2016

Event ID: 73765

Reason for Recall:

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.

Status: Terminated

Product Quantity: 33 filters

Code Information:

Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) All Acne Filters manufactured and Distributed Between: August 04 2015 and November 06 2015

Distribution Pattern:

Distributed in the states of GA, CA, CO, CT, KY, LA, MA, MN, NJ, NY, RI, and SC, and the countries of Italy, Germany, France, and China.

Voluntary or Mandated:

Voluntary: Firm initiated