Z-1669-2016Class II

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

Name: Z-1669-2016 Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971)
Creator: Lumenis Ltd
Published: 2015-11-17
License: https://open.fda.gov/license/

Lumenis Ltd / initiated 2015-11-17 / Terminated / root cause: design

FDA source

Lumenis Ltd began a recall of Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971) on 2015-11-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1669-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-17
Posted: 2016-05-13
Terminated: 2016-11-30
Recalling firm: Lumenis Ltd
Product: Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
Product code: GEX Powered Laser Surgical Instrument
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.
Root cause tag: design
FDA root cause: Device Design
Action: Customers were notified on November 17, 2015 by Customer Notification Letter and customers were asked to return the device.
Quantity in commerce: 33 filters
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1669-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1669-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-13

Product code GEX

K142860Class IILumenis M22 SystemLumenis, Ltd. / cleared 2015-01-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)