# FDA recall Z-2344-2025

> **LUMENIS, LTD.** · Class II · device recall initiated 2025-07-22.

## 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 for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-2344-2025
- **Recalling firm:** LUMENIS, LTD.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-22
- **Report date:** 2025-08-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Yokne'Am Ilit, N/A, Israel

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2344-2025

## Citation

> AI Analytics. FDA recall Z-2344-2025. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-2344-2025. Source: US FDA. Licensed CC0.

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