SoClean, Inc recalls SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System

Recall date

November 15, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0694-2024

FDA classification

Class II

Brand / firm

SoClean, Inc

Sold / distributed

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…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System