Data Foundry

Medical device recalls 2021

The product is a handheld ultraviolet-C germicidal wand and contains… — Class II medical device recall Z-0246-2022

Ongoing recall by MAX LUX CORP, reported 2021-12-08, distributed nationwide. Excessive ultraviolet-C radiation

Recall numberZ-0246-2022
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedFDA mandated
Recalling firmMAX LUX CORP, Yangjiangyangjiang, China
Recall initiated2021-10-26
Classified2021-11-29
Reported by FDA2021-12-08
DistributedNationwide (US)
Quantity9,900 units

Product

The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.

Reason for recall

Excessive ultraviolet-C radiation

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-0246-2022. 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.