AirLife™ 557019500Recalls & reported problems
AirLife Finland Oy · HMEF 1000/S with Flexible Tube and Double Swivel Elbow, Disposable · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190752139848), received between Oct 21, 2020 and Oct 21, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Leak/Splash” (2 reports).
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.
Most reported problems
Device problems
- Leak/Splash2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 21, 2020Leak/Splash; Leak/Splash
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT TWO AIRLIFE HMEF 1000/S WITH FLEXIBLE TUBE AND DOUBLE SWIVEL ELBOW, DISPOSABLE LEAKS ON 2 ANESTHESIA CIRCUITS (180ML). THE ISSUE OCCURRED DURING PATIENT-USE AND THE DEFECTIVE FILTERS WERE REPLACED. THE CUSTOMER ALSO INDICATED THAT DUE TO THE ISSUE, PATIENT MANAGEMENT WAS DELAYED. NO PATIENT HARM WAS NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10713365 ↗InjuryOct 21, 2020Leak/Splash; Leak/Splash
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT TWO AIRLIFE HMEF 1000/S WITH FLEXIBLE TUBE AND DOUBLE SWIVEL ELBOW, DISPOSABLE LEAKS ON 2 ANESTHESIA CIRCUITS (180ML). THE ISSUE OCCURRED DURING PATIENT-USE AND THE DEFECTIVE FILTERS WERE REPLACED. THE CUSTOMER ALSO INDICATED THAT DUE TO THE ISSUE, PATIENT MANAGEMENT WAS DELAYED. NO PATIENT HARM WAS NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10713358 ↗
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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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