Germicidal wands recalled because they emit unsafe levels of UVC radiation
A handheld ultraviolet-C germicidal wand is recalled because it emits an unsafe level of UVC radiation, reaching the Risk Group 3 exposure limit in about 2.2 minutes and risking skin and eye injuries.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice describes a radiation safety defect creating a risk of skin and eye injuries, with no injuries reported.
Plain-English summary
The product is a handheld ultraviolet-C germicidal wand containing narrow-diameter tubular lamps with a peak emission wavelength in the 254 nm range, SKU BT-GERMWAND-LRG-WHT, tested September 8-10, 2020. Distribution was in the United States.
The product emits an unsafe level of UVC radiation, reaching the exposure limit for Risk Group 3, the high risk category, in about 2.2 minutes. The notice states the product has a radiation safety defect, in that these radiation emissions are unnecessary to accomplishing the product's primary purpose of disinfecting objects and surfaces, and create a risk of skin and/or eye injuries to the user and others nearby. The FDA classified the action as Class II.
Anyone holding this product should stop using it and follow the manufacturer's instructions.
The recalled product
- 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.
- Manufacturer
- BigTree Sales Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- SKU BT-GERMWAND-LRG-WHT and Testing: September 8-10
- 2020
Distribution
Distribution scope not specified by the agency.
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