Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SoClean 3 Recalled by SoClean, Inc Due to New User Manual with additional instructions for use...

Date: November 15, 2023
Company: SoClean, Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact SoClean, Inc directly.

Affected Products

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

Quantity: 40,075

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About SoClean, Inc

SoClean, Inc has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report