Peterborough, NH, United States
SoClean, Inc recalls
1 recall recorded since 2018, most recently on 15 November 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 15 November 2023
- 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.
- 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 A
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0695-2024, Z-0694-2024
- SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.
- SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.