SoClean 3 CPAP Cleaner Recalled Over Ozone Exposure Risk
SoClean, Inc is voluntarily recalling 40,075 units of the SoClean 3 sleep equipment cleaner due to potential ozone gas exposure. The manufacturer is providing an updated user manual with safety instructions and a protective hose and mask adapter.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall for a risk-of-harm product (ozone exposure) where no illnesses or injuries have been reported. The hazard is real but mitigated through user instructions and protective equipment.
Plain-English summary
The SoClean 3 (Model SC1400) is an automated cleaning and maintenance system for CPAP equipment used in sleep therapy. The device is being recalled due to potential health risks from ozone gas exposure that can occur after the device is used.
This voluntary recall affects 40,075 units distributed worldwide, including throughout the United States and 34 other countries. The recall was initiated by SoClean, Inc, the manufacturer, to reduce potential health risks to users and caregivers.
To address the hazard, the manufacturer is providing an updated user manual containing additional instructions for use, along with a protective hose and mask adapter. Consumers who own this device should review the updated manual and use the provided adapter to reduce exposure to ozone gas after device operation.
The recalled product
- Product
- SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System
- Manufacturer
- SoClean, Inc
- Hazard
- Affected units
- 40,075
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: (01)00858242007147
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by SoClean, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · SoClean, Inc
See all →- ModerateSoClean 2 Supplemental Hose and Mask System Ozone Exposure Recall
FDA (Devices) · 2024-01-17
Same hazard · ozone exposure
See all →- HighLightStrike Blackout Curtains Recalled Due to Inadequate UV and Ozone Protection
FDA (Devices) · 2024-05-01
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