Lumenis Ltd
FDA adverse event reports naming Lumenis Ltd as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: LUMENIS LTD.
- Total reports
- 3,207
- Deaths
- 3
- Injuries
- 410
- Malfunctions
- 2,778
Reports per year
Source: FDA adverse event reports by year received, 2006–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
Recent recalls
- 2025-08-21Open, ClassifiedNonconforming Material/Component
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
The potential for unsterilized product within finished product labeled as sterile.
- 2025-03-05Open, ClassifiedUnder Investigation by firm
(1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System.
The initial current in certain chargers may lead to overheating and damage to the power resistors on the Alternating Current (AC) controller during the power-on sequence of the laser system, resulting in the laser system to not power on.
- 2016-05-13TerminatedDevice Design
Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
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.
Monitor Lumenis Ltd automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.