AirLife™ 001267URecalls & reported problems
Airlife · Airlife™ Pediatric Oxygen Mask Vinyl, Under the Chin Style, High Concentration, Rebreather Mask (No Valves) with 7 feet (2.1 m) Crush Resistant Oxygen Tubing and U/Connect-It Adapter · 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 10889483569719), received between Oct 31, 2025 and Oct 31, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Filling 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Filling Problem1
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.
InjuryOct 31, 2025Filling Problem; Filling Problem
THE PATIENT DID NOT GET ENOUGH AIR / THE INFLATION BAG DID NOT AUTOMATICALLY FILL WITH OXYGEN (O2); THE O2 DECLINED (DID NOT DELIVER 100% O2). THERE WAS NO REPORTED INJURY.
Patient problems: Low Oxygen Saturation
MAUDE report 23444275 ↗
Other Mask, Oxygen devices
- HUDSON RCI HUDRHO41UMedline Industries, Inc. · MASK, OXYGEN1 recall27 reports
- HUDSON RCI HUD1930Medline Industries, Inc. · MASK, OXYGEN1 recall12 reports
- Mask, Adult Aerosol, Vented 0250Westmed, Inc. · Mask, Oxygen8 reports
- F&P FlexiTrunk BC801-10Fisher & Paykel Healthcare Limited · Mask, Oxygen4 reports
- HUDSON RCI HUD1007Medline Industries, Inc. · MASK, OXYGEN4 reports
- Disposable Face Mask 000252956Ambu A/S · MASK, OXYGEN4 reports
- AcuCare 60788Resmed Pty Ltd · Mask, Oxygen4 reports
- AcuCare 60786Resmed Pty Ltd · Mask, Oxygen2 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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