CLASS II ONGOING Device recall · Reported 24 Sep 2025 · FDA Enforcement Report
The product is a handheld ultraviolet-C germicidal wand recalled
BigTree Sales is recalling The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter. The recall was initiated on 29 Aug 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2571-2025
- FDA event ID
- 97621
- Recalling firm
- BigTree Sales, Arcadia, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Aug 2025
- FDA classified
- 18 Sep 2025
- Reported
- 24 Sep 2025
- Type
- FDA Mandated
- Customers notified by
- N/A
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 29 Aug 2025 | Recall initiated by company | |
| 18 Sep 2025 | Classified by FDA | +20 days |
| 24 Sep 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
U.S.A
Questions about this recall
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.
Which lots are affected?
SKU BT-GERMWAND-LRG-WHT and Testing: September 8-10, 2020
Where was it sold?
U.S.A
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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