FDANovember 15, 2023device
SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
soclean
UPCs
00858242007147
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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