# FDA recall Z-0804-2025

> **IDS LTD** · Class II · device recall initiated 2024-10-16.

## Product

Smaxel Fractional CO2 Laser, a Class IV medical laser system.

## Reason for recall

The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.

## Distribution

Worldwide - US Nationwide Distribution

## Key facts

- **Recall number:** Z-0804-2025
- **Recalling firm:** IDS LTD
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-16
- **Report date:** 2025-01-15

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Paju, Korea (the Republic of)

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0804-2025

## Citation

> AI Analytics. FDA recall Z-0804-2025. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0804-2025. Source: US FDA. Licensed CC0.

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