LUMENIS, LTD. recalls OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incisio…

Recall date

July 22, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2344-2025

FDA classification

Class II

Brand / firm

LUMENIS, LTD.

Sold / distributed

Domestic: PA, WI; International: Germany, India;

Why it was recalled

The potential for unsterilized product within finished product labeled as sterile.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.