FDA recall record

BigTree Sales The product is a handheld ultraviolet-C germicidal wand and contains a recall — FDA Z-2571-2025

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).…

Class IIclassification
Z-2571-2025official record ID
Sep 24, 2025report date

Recall record at a glance

Official recordZ-2571-2025
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmBigTree Sales Inc.
Report dateSep 24, 2025
Recall initiation dateAug 29, 2025
QuantityN/A
LocationArcadia, CA, United States

Official product description

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.

Why the product was recalled

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 information

U.S.A

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: FDA Mandated. Initial notification: N/A.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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