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Recall Observatory FDA recall evidence

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.

Z-2571-2025

August 29, 2025

Class II

Product summary

Firm
BigTree Sales Inc.
Event
Event 97621
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2571-2025

Official wording

Reason: 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.

Code information: SKU BT-GERMWAND-LRG-WHT and Testing: September 8-10, 2020

Distribution pattern: U.S.A

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.