Lumenis recalls
Lumenis has 10 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 27 Aug 2025. 2 are still ongoing.
Total recalls10since 2013
Last 12 months0reported
Class I220% of total
Ongoing2latest 27 Aug 2025
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 2 20%Class II 8 80%Class III 0 0%
Why lumenis is recalled
Product types
By year
Ongoing lumenis recalls
2 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | OtoLase Starter Kit recalled by Lumenis | Lumenis | Sterility | PA, WI |
| Device | CLASS II | Lumenis Pulse 120H 30 amp recalled | Lumenis | Other | PA |
All lumenis recalls, newest first
10 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | OtoLase Starter Kit recalled by Lumenis | Lumenis | Sterility | PA, WI |
| Device | CLASS II | Lumenis Pulse 120H 30 amp recalled | Lumenis | Other | PA |
| Device | CLASS I | IPL Coupling Gel, I L (AX1009013) of (AX1009018) recalled by Lumenis | Lumenis | Other | Nationwide |
| Device | CLASS II | FemTouch delivery system includes the FemTouch Kit recalled by Lumenis | Lumenis | Other | |
| Device | CLASS II | M22 System recalled by Lumenis | Lumenis | Other | 12 states |
| Device | CLASS II | VersaCut+ Tissue Morcellator GA-0007500 The Lumenis recalled | Lumenis | Other | 5 states |
| Device | CLASS II | Light Sheer Desire Diode Laser System recalled by Lumenis | Lumenis | Device Malfunction | Nationwide |
| Device | CLASS II | Array LaserLink recalled by Lumenis | Lumenis | Other | Nationwide |
| Device | CLASS II | Vision One Laser System recalled by Lumenis | Lumenis | Other | IL, NJ, PA |
| Device | CLASS I | VersaCut Tissue Morcellator recalled by Lumenis | Lumenis | Other | Nationwide |
About this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.