iQ 2 Nasal Vented Mask — Class I medical device recall Z-1356-2024
Ongoing recall by SleepNet Corporation, reported 2024-04-10, distributed nationwide. Update to contraindications and warning language due to CPAP masks containing magnets.
| Recall number | Z-1356-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SleepNet Corporation, Hampton, NH, United States |
| Recall initiated | 2024-03-01 |
| Classified | 2024-04-01 |
| Reported by FDA | 2024-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BH, BR, CH, CO, CR, DE, EC, ES, FI, FR, GB, GR, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, MA, MX, MY, NL, NO, OM, PL, QA, RO, RU, SA, SE, SK, SV, TR, UY, VN, ZA |
| Quantity | 2,477 units |
Product
iQ 2 Nasal Vented Mask
Reason for recall
Update to contraindications and warning language due to CPAP masks containing magnets.
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-1356-2024. 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.