The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emissi
Summary
The FDA issued a Class II for The product is a handheld ultraviolet-C germicidal wand and contains a narrow-di by BigTree Sales Inc.. 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 minute.
Details
Source
Device Recall
External ID
Z-2571-2025
Action Date
2025-09-24
Status
Ongoing
Category
device
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.
Lot/Code Info: SKU BT-GERMWAND-LRG-WHT and Testing: September 8-10, 2020
Quantity Affected: N/A
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
Type: FDA Mandated
Recall Initiated: 2025-08-29
Company
Arcadia, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 133 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BigTree Sales Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BigTree Sales Inc. have FDA actions?
This is the only FDA action we have on record for BigTree Sales Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2571-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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