Z-2571-2025Class II

The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a...

Name: Z-2571-2025 The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a...
Creator: BigTree Sales Inc.
Published: 2025-08-29
License: https://open.fda.gov/license/

BigTree Sales Inc. / initiated 2025-08-29 / Open, Classified

FDA source

BigTree Sales Inc. began a recall of 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 on 2025-08-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2571-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-29
Posted: 2025-09-18
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.
Product code: RHP Uv Lamp, Germicidal
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.
FDA 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).
Distribution: U.S.A
Product codes and lots: SKU BT-GERMWAND-LRG-WHT and Testing: September 8-10, 2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2571-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2571-2025	Class II	Ongoing	FDA Mandated	2025-09-24	2025-09-18

Product code RHP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)