FDA Medical Device Recalls (openFDA)
Uvlizer c/o RAIS INTERNATIONAL LLC: The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure mercury bulbs with a peak emission wavelength at 254 nm.
- Recall number
- Z-1807-2026
- Recalling firm
- Uvlizer c/o RAIS INTERNATIONAL LLC
- Product
- The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure mercury bulbs with a peak emission wavelength at 254 nm.
- Status
- Open, Classified
- Initiated
- 2026-03-06
- Posted
- 2026-04-17
- Terminated
- not on file
- 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.
- Root 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
- 480,000
- Distribution
- U.S.
- Lot, serial or model codes
- None provided.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RHP
- Firm FEI
- 3031733296
- Firm city
- Lewes
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28