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U.S. Department of Health and Human Services

Class 2 Device Recall UVO (also referred to as UVO254", Uvlizer, Uvlizer Tower, Uvlizer Home Disinfecting Device

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 Class 2 Device Recall UVO (also referred to as UVO254", Uvlizer, Uvlizer Tower, Uvlizer Home Disinfecting Devicesee related information
Date Initiated by FirmMarch 06, 2026
Date PostedApril 17, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1807-2026
Recall Event ID 98747
Product Classification Uv lamp, germicidal - Product Code RHP
ProductThe product is a handheld ultraviolet-C germicidal wand and contains two low-pressure mercury bulbs with a peak emission wavelength at 254 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 2
Radiation Control for Health and Safety Act
ActionNotifications 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 Commerce480,000
DistributionU.S.
Total Product Life CycleTPLC 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.
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