Quattro Air FFM MED AMER — Class II medical device recall Z-2550-2016
Terminated recall by Resmed Corporation, reported 2016-08-24, distributed nationwide. Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain a non-vented
| Recall number | Z-2550-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Resmed Corporation, San Diego, CA, United States |
| Recall initiated | 2016-07-12 |
| Classified | 2016-08-16 |
| Reported by FDA | 2016-08-24 |
| Terminated | 2016-09-26 |
| Distributed | Nationwide (US) |
| Quantity | 42 units |
| Lot numbers | 1142623 |
Product
Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators
Reason for recall
Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain a non-vented (NV) Quattro Air FFM Large mask.
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-2550-2016. 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.