ClearanceBrief
Recall Z-2571-2025 ยท RHP Uv Lamp, Germicidal

BigTree Sales Inc.

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.

DateSep 18, 2025 (initiated Aug 29, 2025)
StatusOpen, Classified
ReasonThe 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.
Root causeRadiation Control for Health and Safety Act
ActionBigTree Sales, Inc. notified FDA and their customers as required by 21 CFR 1003.10(b), that their electronic product, Portable UV-C Light Sanitizer Wand/Travel UV Sanitizing Wand, model: HH1103/HD-UV-01PL03 (SKU BT-GERMWAND-LRG-WHT), has been discovered to contain a defect related to its safety. Their customer letter was sent with the knowledge of the U.S. Food and Drug Administration (FDA).
DistributionU.S.A
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.