Z-0694-2024Class II

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

Name: Z-0694-2024 SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System
Creator: SoClean, Inc
Published: 2023-11-15
License: https://open.fda.gov/license/

SoClean, Inc. / initiated 2023-11-15 / Open, Classified / root cause: labeling and UDI

FDA source

SoClean, Inc began a recall of SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System on 2023-11-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0694-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-15
Posted: 2024-01-10
Recalling firm: SoClean, Inc.
Product: SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System
Product code: QXQ Respiratory Accessory Microbial Reduction Device.
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: An Urgent Medical Device Correction notice was issued November 16, 2023 advising customers: 1) Do not use your SoClean2 or SoClean3 without the hose and mask adapter provided by the manufacturer. 2) Review revised labeling and User Manuals for: additional warnings and set-up instructions to enable appropriate use; additional instructions for events in which a user is unable to smell residual ozone; additional clarity and consistency regarding that the SoClean2 and SoClean3 are not intended to replace CPAP manufacturers cleaning instructions but rather are to be used to supplement cleaning procedures for home use CPAP masks and tubing. 3) With each SoClean filter purchase, SoClean is supplying a complementary (no additional cost) Hose and Mask Adapter, which facilitates use of the SoClean2 and SoClean3 equipment without ozone entering the CPAP. Set-up Instructions for the Hose and Mask Adapter are included in the updated manuals. To obtain a no cost Hose and Mask Adapter, please contact our Customer Care team at 866-501-3705 or visit the SoClean website: https://www.soclean.com/field-correction. 4) As stated in the SoClean User Manual, patients with underlying lung diseases, such as asthma and chronic obstructive pulmonary disease (COPD, including emphysema and chronic bronchitis), and those with cardiovascular disease, may be sensitive to ozone and should consult with their health care provider before using a SoClean device. Customers are asked to confirm receipt of the recall notification online at the through the hyperlink embedded in the notice https://www.soclean.com/field-correction. Contact Customer Care at 866-501-3705 with questions.
Quantity in commerce: 40,075
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.
Product codes and lots: UDI: (01)00858242007147

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0694-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0694-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-10
Z-0695-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-10

Product code QXQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)