AirLife™ Adult Oxygen Mask Vinyl, Under the Chin Style 001205Recalls & reported problems
Vyaire Medical, Inc. · AirLife™ Adult Oxygen Mask Vinyl, Under the Chin Style, High Concentration Rebreather Mask (No Valves) with 7 feet (2.1 m) Crush Resistant Oxygen Tubing · Class 1
Data updated Oct 18, 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 10190752116344), received between Dec 19, 2023 and Dec 19, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Inflation Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 19, 2023Inflation Problem; Inflation Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THAT FOR THE MANAGEMENT OF PATIENTS WITH OAP, THEY LOGICALLY USED THE AIRLIFE¿ ADULT OXYGEN MASK VINYL, UNDER THE CHIN STYLE, HIGH CONCENTRATION REBREATHER MASK (NO VAVLES) WITH 7 FEET (2.1 M) CRUSH RESISTANT OXYGEN TUBING WITH 100% FIO2 (FRACTION OF INSPIRED OXYGEN). HOWEVER, FOR SOME TIME NOW, THEY HAVE BEEN EXPERIENCING A PROBLEM WITH ITS IMPLEMENTATION. DESPITE HIGH OXYGEN FLOW, SUITABLE PLACEMENT ON THE FACE, THE RESERVOIR OF THESE MASKS REMAINS FLAT. NO SUFFICIENT FILLING IS POSSIBLE. THIS MASK IS INEFFECTIVE DESPITE THE FACT THAT THE AIR INTAKES ON BOTH SIDES OF THE MASKS ARE SEALED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18360454 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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