FDA Device recall Z-2550-2016
Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators
- FDA Device
- Class II
- terminated
- Published 2016-08-24
On 2016-08-24 the FDA classified a Class II recall of Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators by Resmed, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2550-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-12 |
| Published | 2016-08-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Resmed |
| Distribution | US |
Product
Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators
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.
Identifiers
| code_info | Lot 1142623 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2550-2016%22
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