FDA Medical Device Recalls (openFDA)
BigTree Sales Inc.: 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.
- Recall number
- Z-2571-2025
- Recalling firm
- BigTree Sales Inc.
- 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.
- Status
- Open, Classified
- Initiated
- 2025-08-29
- Posted
- 2025-09-18
- Terminated
- not on file
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- BigTree Sales, Inc. notified FDA and their customers as required by 21 CFR 1003.10(b), that their electronic product, Portable UV-C Light Sanitizer Wand/Travel UV Sanitizing Wand, model: HH1103/HD-UV-01PL03 (SKU BT-GERMWAND-LRG-WHT), has been discovered to contain a defect related to its safety. Their customer letter was sent with the knowledge of the U.S. Food and Drug Administration (FDA).
- Quantity
- not on file
- Distribution
- U.S.A
- Lot, serial or model codes
- SKU BT-GERMWAND-LRG-WHT and Testing: September 8-10, 2020
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RHP
- Firm FEI
- 3039602167
- Firm city
- Arcadia
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28