Medical device recalls Moderate risk

BigTree Sales Inc. recalls The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emiss…

Recall date
August 29, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2571-2025
FDA classification
Class II
Brand / firm
BigTree Sales Inc.
Sold / distributed
U.S.A

Why it was recalled

The subject product emits unsafe level of UVC radiation (i.e., the product reaches the exposure limit for Risk Group 3 (high risk) in about 2.2 minutes). The product has a radiation safety defect, in that these radiation emissions are unnecessary to the accomplishment of the product s primary purpose of disinfecting objects and surfaces, and create a risk of skin and/or eye injuries to user and nearby persons.

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

What was recalled

The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.

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