AirLife™ 001363Recalls & reported problems
Vyaire Medical, Inc. · AirLife™ Adult Venturi Style Mask Vinyl, Under-the-Chin Style Adult Mask, 6 inch (15 cm) Flextube, Six Diluter Jets, Nebulizer Hood, 7 feet (2.1 m) Oxygen Tubing and U/Connect-It Adapter · Class 1
All models of AirLife (25)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190752116689), received between Dec 10, 2024 and Dec 10, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incomplete or Missing Packaging” (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
- Incomplete or Missing Packaging1
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.
MalfunctionDec 10, 2024Incomplete or Missing Packaging; Incomplete or Missing Packaging
IT WAS REPORTED THAT THEY RETRIEVED AN AIRLIFE VENTURI FACEMASK PACKAGE FROM THE SUPPLY ROOM AND DELIVERED IT TO THE PATIENT'S (PT) ROOM. THE AIRLIFE PACKAGING DID NOT APPEAR TO BE OPEN BUT WAS MISSING THE FACE MASK AND 6-INCH FLEXTUBE. BECAUSE THE PT NEEDED TO BE TRANSPORTED FOR AN EMERGENT CT AND THERE WAS NO TIME TO LOOK FOR A COMPLETE AIRLIFE PACKAGE, A NONREBREATHER WAS USED FOR TRANSPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20897774 ↗
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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