# FDA recall Z-0694-2024

> **SoClean, Inc** · Class II · device recall initiated 2023-11-15.

## Product

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

## Reason for recall

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.

## 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 Emirates, and United Kingdom.

## Key facts

- **Recall number:** Z-0694-2024
- **Recalling firm:** SoClean, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-15
- **Report date:** 2024-01-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Peterborough, NH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0694-2024

## Citation

> AI Analytics. FDA recall Z-0694-2024. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0694-2024. Source: US FDA. Licensed CC0.

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