Skip to content
Recall Observatory FDA recall evidence

Device product

SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.

Z-0695-2024

November 15, 2023

Class II

Product summary

Firm
SoClean, Inc
Event
Event 93570
Status
Ongoing
Classification
Class II
Quantity
2,339,352
Official record key
device-enforcement:Z-0695-2024

Official wording

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.

Code information: UPC: 187293000860

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.