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AirLife™ 001203Recalls & reported problems

Vyaire Medical, Inc. · AirLife™ Adult Oxygen Mask Vinyl, Under the Chin Style, 3 in 1 Mask with Safety Vent, with 7 feet (2.1 m) Crush Resistant Oxygen Tubing · Class 1

All models of AirLife (25)

Data updated Oct 16, 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 10190752116320), received between Jun 12, 2020 and Jun 12, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (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 16, 2026.

Most reported problems

Device problems

  • Material Separation1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 12, 2020Material Separation; Material Separation

    THE CUSTOMER REPORTED THAT THE NON-REBREATHER BAG WAS DISCONNECTED FROM THE MASK WHILE CONNECTED TO A PATIENT. THE NURSE REPLACED THE DEFECTIVE UNIT WITH A BACK UP BAG. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10150911 ↗

Other MASK, OXYGEN, NON-REBREATHING devices

All MASK, OXYGEN, NON-REBREATHING devices →

Sources and updates

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