FDA Device recall Z-0695-2024
SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System
- FDA Device
- Class II
- ongoing
- Published 2024-01-17
On 2024-01-17 the FDA classified a Class II recall of SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System by Soclean, citing 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 he….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0695-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-15 |
| Published | 2024-01-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Soclean |
| Distribution | US |
Product
SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.
Reason
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.
Identifiers
| upc | 187293000860 |
|---|---|
| code_info | UPC: 187293000860 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0695-2024%22
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