# FDA recall Z-0146-2026

> **Lutronic Corporation** · Class II · device recall initiated 2025-09-04.

## Product

XERF EFFECTOR 60. Electrosurgical unit.

## Reason for recall

Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.

## Distribution

Worldwide - US Nationwide distribution in the states of CA, IL, MA, NJ, NY, PA, TX, and UT. The countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.

## Key facts

- **Recall number:** Z-0146-2026
- **Recalling firm:** Lutronic Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-04
- **Report date:** 2025-10-22

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0146-2026

## Citation

> AI Analytics. FDA recall Z-0146-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0146-2026. Source: US FDA. Licensed CC0.

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