Recall Z-1808-2026— Uvlizer c/o RAIS INTERNATIONAL LLC
Class II · Ongoing
Class II FDA medical device recall by Uvlizer c/o RAIS INTERNATIONAL LLC, initiated 2026-03-06. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Uvlizer c/o RAIS INTERNATIONAL LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-06
- Firm location
- Lewes, DE, United States
Product 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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.