SoClean 2 — Class II medical device recall Z-0695-2024
Ongoing recall by SoClean, Inc, reported 2024-01-17, distributed nationwide. New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufa
| Recall number | Z-0695-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SoClean, Inc, Peterborough, NH, United States |
| Recall initiated | 2023-11-15 |
| Classified | 2024-01-10 |
| Reported by FDA | 2024-01-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, CA, CH, CL, CO, DE, EG, ES, FR, GB, HK, IL, IT, JO, JP, KR, LK, LT, MX, NL, NZ, PT, RU, SA, SG, SV, TH, TR |
| Quantity | 2,339,352 |
| UPC / GTIN / UDI-DI | 00187293000860 |
| Model numbers | C1200 |
Product
SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0695-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.