SoClean 2 Supplemental Hose and Mask System Ozone Exposure Recall
SoClean is recalling its SoClean 2 hose and mask maintenance system to reduce potential ozone gas exposure risks. An updated user manual and replacement adapter will be provided by the manufacturer.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II medical device recall that is voluntary in nature. No injuries or illnesses have been reported, and the hazard is characterized as potential rather than realized. The remedy is primarily educational (updated manual) combined with a hardware adapter.
Plain-English summary
SoClean, Inc is recalling the SoClean 2, REF SC1200 Supplemental Hose and Mask Maintenance System. Approximately 2,339,352 units have been distributed worldwide, including throughout the United States.
The recall is intended to help reduce potential health risks from ozone gas exposure. This is a voluntary recall. The manufacturer is providing a new user manual with additional use instructions and a replacement hose and mask adapter to help reduce exposure risks.
Additional information about this recall (Z-0695-2024) is available from the FDA.
The recalled product
- Product
- SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.
- Manufacturer
- SoClean, Inc
- Affected units
- 2,339,352
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)
- UPC: 187293000860
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
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