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LUMENIS, LTD. recalls OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incis
Recalled August 27, 2025 · FDA recall Z-2344-2025 · LUMENIS
Hazard
The potential for unsterilized product within finished product labeled as sterile. · FDA Class II
Units
13 units
Sold at
Domestic: PA, WI; International: Germany, India;
Description
The potential for unsterilized product within finished product labeled as sterile.
Product
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
Manufacturer(s)
LUMENIS, LTD.
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →