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OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablat...

FDA Recall #Z-2344-2025 — Class II — July 22, 2025

Recall #Z-2344-2025 Date: July 22, 2025 Classification: Class II Status: Ongoing

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.

Recalling Firm

LUMENIS, LTD. — Yokne'Am Ilit, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

13 units

Distribution

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

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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