CLASS II Device recall · Reported 25 May 2016 · FDA Enforcement Report
M22 System recalled by Lumenis
Lumenis is recalling M22 System, distributed in 12 states. The recall was initiated on 17 Nov 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1669-2016
- FDA event ID
- 73765
- Recalling firm
- Lumenis, Yokneam, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Nov 2015
- FDA classified
- 13 May 2016
- Reported
- 25 May 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 17 Nov 2015 | Recall initiated by company | |
| 13 May 2016 | Classified by FDA | +178 days |
| 25 May 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
Where it was distributed
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.
CaliforniaColoradoConnecticutGeorgiaKentuckyLouisianaMassachusettsMinnesotaNew JerseyNew YorkRhode IslandSouth Carolina
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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