FDA Device recall Z-1669-2016
Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971)
- FDA Device
- Class II
- terminated
- Published 2016-05-25
On 2016-05-25 the FDA classified a Class II recall of Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971) by Lumenis, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1669-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-17 |
| Published | 2016-05-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Lumenis |
| Distribution | CA, CO, CT, GA, KY, LA, MA, MN, NJ, NY, RI, SC |
Product
Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
Reason
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.
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1669-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.