# FDA recall Z-1558-2026

> **Lutronic Corporation** · Class II · device recall initiated 2026-01-27.

## Product

CLARITY II Laser System; Model No. 1110200210.

## Reason for recall

Reports of devices sparking/popping and potentially burning patients.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.

## Key facts

- **Recall number:** Z-1558-2026
- **Recalling firm:** Lutronic Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-27
- **Report date:** 2026-03-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Goyang, N/A, Korea (the Republic of)

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1558-2026

## Citation

> AI Analytics. FDA recall Z-1558-2026. Retrieved 2026-07-29 from https://api.ai-analytics.org/recall/Z-1558-2026. Source: US FDA. Licensed CC0.

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