AirLife™ 001362Recalls & reported problems
Vyaire Medical, Inc. · AirLife™ Adult Oxygen Mask Vinyl, Under-the-Chin Style, 3 in 1 Mask With 7 feet (2.1 m) Crush-Resistant Tubing and U/Connect-It Adapter · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190752116276), received between Aug 4, 2021 and Aug 4, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Puncture/Hole1
Patient problems
- Low Oxygen Saturation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 4, 2021Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 001362 AIRLIFE¿ ADULT OXYGEN MASK VINYL, UNDER-THE-CHIN STYLE, 3 IN 1 MASK WITH 7' (2.1 M) CRUSH-RESISTANT TUBING AND U/CONNECT-IT ADAPTER HAS A HOLE NEAR THE TOP OF THE BAG WHERE IT CONNECTS TO THE FACE MASK. THE BAG NOT FILLING WITH OXYGEN NOR WAS IT ABLE TO PROVIDE ADEQUATE RELIEF WITH DESATURATION. A NEW NON-REBREATHER WAS GIVEN TO THE PATIENT, AND SHE WAS ABLE TO RECOVER WITHOUT HARM.
Patient problems: Low Oxygen Saturation
MAUDE report 12274253 ↗
Other CANNULA, NASAL, OXYGEN devices
- Fisher & Paykel Healthcare OPT844Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen39 reports
- Fisher and Paykel Healthcare OPT312Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen22 reports
- Fisher and Paykel Healthcare OPT314Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen17 reports
- O2 Cannula 001366Salter Labs · Cannula, Nasal, Oxygen10 reports
- O2 Cannula 001365Salter Labs · Cannula, Nasal, Oxygen9 reports
- N/A 16SOFT-4Salter Labs · CANNULA, NASAL, OXYGEN8 reports
- N/A 1053-7Salter Labs · CANNULA, NASAL, OXYGEN8 reports
- Fisher & Paykel Healthcare OPT842Fisher & Paykel Healthcare Limited · Cannula, Nasal, Oxygen7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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