Data Foundry

Medical device recalls 2025

The product is a handheld ultraviolet-C germicidal wand and contains… — Class II medical device recall Z-2571-2025

Ongoing recall by BigTree Sales Inc., reported 2025-09-24. The subject product emits unsafe level of UVC radiation (i.e., the product reaches the exposure limit for Risk

Recall numberZ-2571-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedFDA mandated
Recalling firmBigTree Sales Inc., Arcadia, CA, United States
Recall initiated2025-08-29
Classified2025-09-18
Reported by FDA2025-09-24

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 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2571-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.