Lumenis M22 System Model Number: GA-0005400 — Class II medical device recall Z-1669-2016
Terminated recall by Lumenis Ltd, reported 2016-05-25, distributed in CA, CO, CT, GA, KY, LA, MA, MN…. Lumenis Ltd Announces a Field Action of the M22 IPL Acne Filters for the Lumenis M22 IPL Hand Piece due to the
| Recall number | Z-1669-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lumenis Ltd, Yokneam, N/A, Israel |
| Recall initiated | 2015-11-17 |
| Classified | 2016-05-13 |
| Reported by FDA | 2016-05-25 |
| Terminated | 2016-11-30 |
| Distributed | CA, CO, CT, GA, KY, LA, MA, MN, NJ, NY, RI, SC |
| Countries outside the US | CN, DE, FR, IT |
| Quantity | 33 filters |
| Model numbers | GA-0005400 |
Product
Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1669-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.