FDA recall Z-2571-2025

BigTree Sales Inc. · Class II · device

Product

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.

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

Key facts

Status
Ongoing
Initiation date
2025-08-29
Report date
2025-09-24
Voluntary/Mandated
FDA Mandated
Location
Arcadia, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2571-2025