Class II — SoClean, Inc
| Recalling firm | SoClean, Inc. |
|---|---|
| Registered facility | SoClean, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufacturer. This voluntary recall is intended to help reduce potential health risks of exposure to ozone gas after the use of a SoClean device. |
| Product | SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System |
| Quantity | 40,075 |
| Distribution | Worldwide distribution - United States Nationwide and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Egypt, El Salvador, England, France, Germany, Hong Kong, Isle of Man, Israel, Italy, Japan, Jordan, Korea, Lithuania, Mexico, New Zealand, Portugal, Russia, Saudi Arabia, Seoul, Singapore, Spain, Sri Lanka, Switzerland, Thailand, Netherlands, Turkey, United Arab E… |
| Initiated | 2023-11-15 |
| Classified | 2024-01-10 |
| Recall number | Z-0694-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — SoClean, Inc (Z-0694-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93570/
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