CLASS II Device recall · Reported 24 Aug 2016 · FDA Enforcement Report
Quattro Air FFM MED AMER, Product recalled by Resmed
Resmed is recalling Quattro Air FFM MED AMER, distributed nationwide in the US. The recall was initiated on 12 Jul 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2550-2016
- FDA event ID
- 74736
- Recalling firm
- Resmed, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jul 2016
- FDA classified
- 16 Aug 2016
- Reported
- 24 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 12 Jul 2016 | Recall initiated by company | |
| 16 Aug 2016 | Classified by FDA | +35 days |
| 24 Aug 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators
Where it was distributed
US nationwide distribution
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot 1142623
Where was it sold?
US nationwide distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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