Recall Z-2344-2025— LUMENIS, LTD.

Name: FDA recall Z-2344-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-22

Class II · Ongoing

Class II FDA medical device recall by LUMENIS, LTD., initiated 2025-07-22. It names one FDA 510(k) clearance: K130164. Product: OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.. Reason: The potential for unsterilized product within finished product labeled as sterile..

Recalling firm: LUMENIS, LTD.
Classification: Class II
Status: Ongoing
Initiated: 2025-07-22
Firm location: Yokne'Am Ilit, N/A, Israel

510(k) clearances named in this recall

1 on FDA's record

K130164 — FIBERLASE ENDURE CO2 FIBERLumenis, Ltd.·cleared 2013-03-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.