Class II

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

LUMENIS, LTD. · July 22, 2025

Reason for Recall

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

Distribution

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

States Affected

PA, WI

Quantity Affected

13 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2344-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

LUMENIS, LTD. Medical Device Recall: OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue. | SafeCheck