Recall Z-2571-2025— BigTree Sales Inc.
Class II · Ongoing
Class II FDA medical device recall by BigTree Sales Inc., initiated 2025-08-29. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- BigTree Sales Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-08-29
- Firm location
- Arcadia, CA, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.