LUMENIS, LTD.: Device Recall

Recall #Z-2344-2025 · 07/22/2025

Class II: Risk

Recall Details

Recall Number: Z-2344-2025
Classification: Class II
Product Type: Device
Recalling Firm: LUMENIS, LTD.
Status: Ongoing
Date Initiated: 07/22/2025
Location: Yokne'Am Ilit, N/A, Israel
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 13 units

Reason for Recall

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

Product Description

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

Distribution Pattern

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

Other Recalls by LUMENIS, LTD.

Class II: Risk 01/23/2025

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.

View all recalls by LUMENIS, LTD. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.