Brand
LUMENIS, LTD.
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for LUMENIS, LTD. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-08-27FDA-DeviceClass IIOtoLase 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.
- 2025-03-12FDA-DeviceClass II(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.
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