Official recall record
Soclean 2
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-08-12
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
The SoClean 2 label and IFU are being updated to address mitigation of risk in relation to the safety of ozone, and to instruct users to use the provided hose and mask adapter (which was added to the device licence by way of amendment) to keep ozone out of the pap machine. Recall start date: July 18, 2025
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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