FDA Enforcement
Class II
Ongoing
The product is a handheld ultraviolet-C germicidal wand and contains a combination of five UV-A and UV-C LED lights. The product comes in two configurations: UV-C x 1; UV-A x 4, or UV-C x 2; UV-A x 3. The product has two peak emission wavelengths at 274 nm and 397 nm.
Recall: Z-1808-2026
·
Reported April 29, 2026
Enforcement
- Recall Number
- Z-1808-2026
- Event ID
- 98742
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Uvlizer c/o RAIS INTERNATIONAL LLC
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- N/A
- Report Date
- April 29, 2026
- Initiation Date
- March 6, 2026
- Classification Date
- April 17, 2026
- Address
- 16192 Coastal Hwy, N/A, Lewes, DE, 19958-3608, United States
Description
The product is a handheld ultraviolet-C germicidal wand and contains a combination of five UV-A and UV-C LED lights. The product comes in two configurations: UV-C x 1; UV-A x 4, or UV-C x 2; UV-A x 3. The product has two peak emission wavelengths at 274 nm and 397 nm.
Reason
In some foreseeable use conditions, the products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.
Code Info
None provided.
Distribution
U.S.
Quantity
334