The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0246-2022·Announced 2021-12-08

UV-C Germicidal Wand Recalled for Excessive Ultraviolet-C Radiation

MAX LUX CORP is recalling approximately 9900 handheld UV-C germicidal wands (Safe-T Lite) distributed nationwide due to excessive ultraviolet-C radiation emissions.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II device recall for a product with potential to cause direct physical harm through UV-C radiation exposure. No illnesses or injuries are reported in the source material, placing it in the Score 3 category: risk-of-harm products where injury has not yet been reported.

Plain-English summary

MAX LUX CORP is recalling the Safe-T Lite, a handheld ultraviolet-C germicidal wand containing two tubular lamps with peak emission at 254 nanometers. The product is designed for disinfecting surfaces and was distributed nationwide. Approximately 9900 units are subject to this recall.

The product emits excessive ultraviolet-C radiation. Ultraviolet-C radiation at elevated levels can pose a health risk to users and others who may be exposed during operation of the device.

Consumers who own this product should stop using it and contact MAX LUX CORP for further instructions.

The recalled product

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.
Manufacturer
MAX LUX CORP
Affected units
9,900

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Safe-T Lite

Distribution

Distributed nationwide across the United States.

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