FDA Medical devices recall ·
The product is a handheld ultraviolet-C germicidal wand and contains a… recall
- Recall number
- Z-2571-2025
- Date
- (initiated August 29, 2025)
- Company / brand
- BigTree Sales Inc.
11715 Clark St, Arcadia, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- N/A
- Hazard tags
- Injury risk
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
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.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
SKU BT-GERMWAND-LRG-WHT and Testing: September 8-10, 2020
Distribution
U.S.A
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2571-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.