Medical Device Recall: 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.
BigTree Sales Inc. · August 29, 2025
Reason for Recall
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.
Distribution
U.S.A
Quantity Affected
N/A
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2571-2025
Status: ongoing
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