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

Recall date

October 16, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0804-2025

FDA classification

Class II

Brand / firm

IDS LTD

Sold / distributed

Worldwide - US Nationwide Distribution

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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