SoClean, Inc: Medical Device Recall in 2024 - (Recall #: Z-0694-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 15, 2023

Date Posted: January 17, 2024

Recall Number: Z-0694-2024

Event ID: 93570

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.

Status: Ongoing

Product Quantity: 40,075

Code Information:

UDI: (01)00858242007147

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.

Voluntary or Mandated:

Voluntary: Firm initiated