Lumenis, Ltd. FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incisClass IIJul 22, 2025The potential for unsterilized product within finished produ	The potential for unsterilized product within finished product labeled as sterile.	Class IIDevices	Jul 22, 2025
(1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, LaClass IIJan 23, 2025The initial current in certain chargers may lead to overheat	The initial current in certain chargers may lead to overheating and damage to the power resistors on the Alter	Class IIDevices	Jan 23, 2025