Voluntary recall of SoClean equipment for CPAP devices
Nov 21, 2023 · This SoClean device recall includes new instructions for device use, including the importance of using a hose and mask adapter provided by the company. This voluntary recall …
SoClean Customer Notification
May 6, 2022 · Health Canada considers the re-labelling to be a recall, so we are writing to you today to notify you of the action taken and to provide you with the following link to the updated …
SoClean Lawsuit: What CPAP Users Should Be Aware Of
Dec 4, 2025 · SoClean is involved in an issue with Philips over claims that its ozone-based cleaning devices caused problems with Philips CPAP machines. The legal battle between …
Class 2 Device Recall SoClean - Food and Drug Administration
Nov 15, 2023 · 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 …
SoClean Issues Voluntary Recall of CPAP Cleaners - Sleep Review
Nov 21, 2023 · SoClean has issued a voluntary recall of its SoClean2 and SoClean3 equipment used to clean, sanitize, or disinfect CPAP devices and accessories after receiving complaints …
The truth about FDA’s Warning on SoClean and Ozone CPAP …
Dec 10, 2024 · In November 2023, the FDA issued a safety communication regarding ozone-based CPAP cleaners, including the SoClean2 and SoClean3, which were part of a voluntary …
FDA warns – SoClean3+ device authorized for marketing despite …
Sep 11, 2024 · In April, 2023, SoClean responded to concerns about possible exposure to dangerous levels of ozone by issuing an updated instruction manual and a hose and mask …
Soclean 2 - Canada.ca - recalls-rappels.canada.ca
Aug 12, 2025 · The SoClean 2 label and IFU are being updated to address mitigation of risk in relation to the safety of ozone, and to instruct users to use the provided hose and mask …
FDA cracks down on ozone cleaners for CPAP machines
Sep 5, 2024 · However, the company recalled its SoClean 2 and SoClean 3 devices last year to add a hose and mask adapter to prevent ozone from entering the CPAP machine. At the time, …
Medical Device RECALL NOTICE - SoClean 2 IFU Revision
Please be advised Canadian Home Healthcare Inc. (CHH) is notifying you with respect to a recall involving all SoClean2 units. The manufacturer SoClean has issued a voluntary Advisory …