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Recall Observatory FDA recall evidence

Device product

The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.

Z-0246-2022

October 26, 2021

Class II

Product summary

Firm
MAX LUX CORP
Event
Event 89050
Status
Ongoing
Classification
Class II
Quantity
9900 units
Official record key
device-enforcement:Z-0246-2022

Official wording

Reason: Excessive ultraviolet-C radiation

Code information: Safe-T Lite

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Excessive ultraviolet-C radiation