BigTree Sales Inc.: Medical Device Recall in 2025 - (Recall #: Z-2571-2025)
See the recall detail below. You can also see other recalls from the same firm in 2025.
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.
Class II
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.
SKU BT-GERMWAND-LRG-WHT and Testing: September 8-10, 2020
U.S.A
FDA Mandated
