SoClean 2 & 3 Voluntary Recall

Link to the recall page - https://cpap.review/soclean-recall Medwatch Reporting Form - https://cpap.review/medwatch SoClean has voluntarily recalled its SoClean2 and SoClean3 devices, used for cleaning CPAP machines, following approximately 7,417 complaints (0.33% of units sold). These complaints often involved difficulty in setting up or turning on the device, unpleasant odors, cough, and worsening of preexisting conditions. The recall does not necessitate users to cease use or return their units. SoClean is updating its labels to include additional warnings, contraindications, and clear set-up instructions, specifically emphasizing the use of the provided hose and mask adapter. This move aims to address risks associated with the previous device design and labeling. The FDA has issued safety communications advising users not to use SoClean2 or SoClean3 without the provided adapter, to disconnect the equipment from CPAP devices during use, and to follow CPAP manufacturers' cleaning instructions. The SoClean manual and the new adapter are designed to reduce ozone exposure risks. The FDA continues to work with SoClean for compliance and reminds that no ozone gas or UV light-based cleaning devices for CPAP machines have been authorized for market. Problems with SoClean devices can be reported through the MedWatch voluntary reporting form.