Class II — Resmed Corporation
| Recalling firm | RESMED CORP. |
|---|---|
| Registered facility | View this company's 7 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators |
| Quantity | 42 units |
| Distribution | US nationwide distribution |
| Initiated | 2016-07-12 |
| Classified | 2016-08-16 |
| Terminated | 2016-09-26 |
| Recall number | Z-2550-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Resmed Corporation (Z-2550-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74736/
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