RecallRadar

FDA Device recall Z-2550-2016

Quattro Air FFM MED  AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators

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

AgencyFDA Device
Recall numberZ-2550-2016
ClassificationClass II
Statusterminated
Initiated2016-07-12
Published2016-08-24
Last updated2026-09-13 11:54 UTC
CompanyResmed
DistributionUS

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_infoLot 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

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.