AirLife 002002Recalls & reported problems
Carefusion Corporation · Airlife™ Nebulizer with Air Entrainment · Class 2
All models of AirLife (23)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403006425), received between Aug 8, 2022 and Aug 2, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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.
Most reported problems
Device problems
- Leak/Splash1
- Moisture or Humidity Problem1
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.
MalfunctionAug 2, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 002002 - NEBULIZER WITH AIR ENTRAINMENT WAS LEAKING FROM BOTTLE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM/INJURY ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17443036 ↗MalfunctionAug 8, 2022Moisture or Humidity Problem; Moisture or Humidity Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 002002 - NEBULIZER WITH AIR ENTRAINMENT DOES NOT HUMIDIFY THE AIR DESPITE BEING REPLACED AND SECURING THE CONNECTION. THE HUMIDIFIED AIR IS NEEDED FOR A PATIENT WITH TRACHEOSTOMY. THERE WERE NO REPORTS OF INJURY/HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15189074 ↗
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- F&P Optiflow Junior 2 OJR412Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)80 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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