Lumenis M22 IPL Acne Filters Recalled for Superficial Burn Risk
Lumenis Ltd is recalling M22 IPL Acne Filters due to a risk of superficial burns when using the device.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of superficial burns, which constitutes a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Lumenis Ltd has announced a field action for the M22 IPL Acne Filters used with the Lumenis M22 IPL Hand Piece. The recall is being conducted due to the risk of superficial burns when using the device.
The affected products are the Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971). A total of 33 filters are involved in this recall. These filters were manufactured and distributed between August 04, 2015, and November 06, 2015.
The products were distributed in the states of GA, CA, CO, CT, KY, LA, MA, MN, NJ, NY, RI, and SC, as well as in the countries of Italy, Germany, France, and China. Users of these devices should stop using the affected filters and contact Lumenis Ltd for further instructions.
The recalled product
- Product
- Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
- Manufacturer
- Lumenis Ltd
- Hazard
- Affected units
- 33
Distribution
Related recalls
Same manufacturer · Lumenis Ltd
See all →- HighOtoLase starter kits recalled over potentially unsterilized product labeled as sterile
FDA (Devices) · 2025-08-27
- ModerateLumenis Pulse 120H Laser System Charger May Prevent Device Startup
FDA (Devices) · 2025-03-12
Same hazard · burn injury
See all →- SevereVQQQ Gas Patio Heaters Recalled for Fire and Burn Hazards
CPSC · 2026-10-22
- HighThomas Built Buses Recalls 2027 Saf-T-Liner C2 School Buses
NHTSA · 2026-10-21
- SevereDR Power Trimmer Mowers Recalled for Fire and Burn Hazards
CPSC · 2026-10-08
- SevereSnow Peak Recalls Propane Fireplace Inserts and Lava Rocks
CPSC · 2026-10-08
- SevereHyundai and Genesis Recall Vehicles Due to Front Seat Fire Risk
NHTSA · 2026-10-08
Similar recalls
- SevereIPL Coupling Gel and EcoGel 200 Recalled for Bacterial Contamination
FDA (Devices) · 2021-11-10
- HighLumenis Vision One Laser System Recalled for Unintended Laser Exposure
FDA (Devices) · 2013-09-18
- HighLumenis Light Sheer Desire Diode Laser System Recalled for Software Error
FDA (Devices) · 2015-05-06
- HighLutronic DermaV Laser System Recalled for Potential Patient Burn Risk
FDA (Devices) · 2026-09-16
- HighLumenis Recalls FemTouch Delivery System Due to Ineffective Cleaning Instructions
FDA (Devices) · 2016-11-02
- ModerateCoapt ControlSeal Electrode Recalled Due to Burn and Blistering Risk
FDA (Devices) · 2023-11-08