FDA Enforcement Class II Ongoing

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.

Recall: Z-0003-2023 · Reported October 12, 2022

Enforcement

Recall Number
Z-0003-2023
Event ID
90860
Classification
Class II
Status
Ongoing
Product Type
Devices
Firm
IN MY BATHROOM LLC
Voluntary / Mandated
FDA Mandated
Initial Notification
Letter
Report Date
October 12, 2022
Initiation Date
January 27, 2022
Classification Date
October 5, 2022
Address
22617 Mariano St, N/A, Woodland Hills, CA, 91367-6127, United States

Description

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.

Reason

Excessive ultraviolet-C radiation

Code Info

Model Seago SG-153

Distribution

US Nationwide Distribution

Quantity

485 units