Class 2 Device Recall MiniUV (also referred to as Pocket UV Sterilizer, model no. U01)

• Date Initiated by Firm: March 06, 2026
• Date Posted: April 17, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1808-2026
• Recall Event ID: 98742
• Product Classification: Uv lamp, germicidal - Product Code RHP
• 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.
• Code Information: None provided.
• FEI Number: 3031733296
• Recalling Firm/ Manufacturer: Uvlizer c/o RAIS INTERNATIONAL LLC; 16192 Coastal Hwy; Lewes DE 19958-3608
• Manufacturer 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.
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: Notifications to purchasers and subsequent transferees will be transmitted through multiple communication channels: Certified Mail, Email Notifications, and Public Website Notice, describing the defect, safety considerations, and instructions to discontinue use of the Product.
• Quantity in Commerce: 334
• Distribution: U.S.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.