LUMENIS, LTD.: Medical Device Recall in 2025 - (Recall #: Z-2344-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 22, 2025

Date Posted: August 27, 2025

Recall Number: Z-2344-2025

Event ID: 97279

Reason for Recall:

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

Status: Ongoing

Product Quantity: 13 units

Code Information:

UPN: AC-2003748; UDI-DI: 07290109142807; Batch Numbers: 32644549 and 32769567; Expiration Date: 22Aug2025;

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated