FDA Device recall Z-2571-2025
The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emission wavelength in th…
- FDA Device
- Class II
- ongoing
- Published 2025-09-24
On 2025-09-24 the FDA classified a Class II recall of The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emission wavelength in th… by Bigtree Sales, citing 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 radiati….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2571-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-29 |
| Published | 2025-09-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Bigtree Sales |
| Distribution | n/a |
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.
Identifiers
| code_info | SKU BT-GERMWAND-LRG-WHT and Testing: September 8-10, 2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2571-2025%22
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