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RecallWatchMedical Device Safety
Class IIOngoingZ-2571-2025

BigTree Sales Inc. recalls The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter

BigTree Sales Inc.Arcadia, CA, United StatesReported Sep 24, 2025 · 9 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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.

Lot / code information

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

What the firm is doing

BigTree 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).

DistributionShow details

U.S.A

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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