AirLife™ 001361Recalls & reported problems
Airlife · AirLife™ Adult Oxygen Mask Vinyl, Under-The-Chin, Medium Concentration Mask with 7 feet (2.1 m) U/Connect-It Crush-Resistant Oxygen Tubing · Class 1
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 10889483570128), received between Nov 6, 2025 and Nov 6, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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.
Reports received per month
Most reported problems
Device problems
- Loose or Intermittent Connection1
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.
InjuryNov 6, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
THE HEALTHCARE FACILITY REPORTED, DIFFICULTY CONNECTING/DISCONNECTING TUBING TO CONNECTORS IN THE OPERATING ROOM/ACUTE SURGICAL UNIT (OR/ASU), WHICH RESULTED IN THE PATIENT DE-SATURATING DUE TO IMPROPER CONNECTION(S). NO INFORMATION WAS PROVIDED CONCERNING IF ANY MEDICAL INTERVENTION WAS REQUIRED; THE PATIENT CONDITION WAS REPORTED TO BE STABLE.
Patient problems: Low Oxygen Saturation
MAUDE report 23490763 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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