AirLife™ 001206Recalls & reported problems
Airlife · AirLife™ Adult Aerosol Mask Vinyl, Under-The-Chin Style · Class 1
Data updated Oct 16, 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 10889483569276), received between Dec 24, 2025 and Dec 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Patient Device Interaction 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
- Patient Device Interaction Problem1
Patient problems
- Eye Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED, DESPITE ATTEMPTS TO REPOSITION THE MASK, IT WAS POKING THE PATIENT IN THE EYES FOR THE DURATION OF THE TREATMENT. IT WAS ADDITIONALLY REPORTED, THERE WAS NO SIGNIFICANT DELAY IN TREATMENT OR EFFECTIVENESS; HOWEVER, A NON-SERIOUS INJURY WAS REPORTED. NO INFORMATION PROVIDED CONCERNING PATIENT OUTCOME.
Patient problems: Eye Injury
MAUDE report 23891201 ↗
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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