AirLife 002620Recalls & reported problems
Carefusion Corporation · Airlife™ Sterile Water for Inhalation, USP, 500 ml. · Class 2
All models of AirLife (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885403070983), received between Apr 9, 2021 and Mar 20, 2023 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Defective Device” (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 18, 2026.
Most reported problems
Device problems
- Defective Device1
- Fitting Problem1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- Low Oxygen Saturation2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2023Fitting Problem; Fitting Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE HUMIDIFIER KIT 500ML 12/CS ADAPTER DOES NOT FIT PROPERLY INTO THE FLOWMETER. DUE TO THIS, A LEAKAGE OCCURRED WHICH CAUSED A LOW OXYGEN SATURATION. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: Low Oxygen Saturation
MAUDE report 16573827 ↗InjuryJun 23, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE CUSTOMER REPORTED THAT THE AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 ML EXPERIENCED MISSING HOLE THAT ALLOWS A CONNECTION TO THE O2 AND THE CANNULA. THE THERAPIST HAD TO POKE A HOLE IN THE TOP AND NASAL CANNULA CONNECTION TO GET IT TO WORK. THE CUSTOMER CONFIRMED THAT PATIENT O2 DESATURATED. BUT WAS CAUGHT IN TIME TO PREVENT FURTHER HARM.
Patient problems: Low Oxygen Saturation
MAUDE report 12052099 ↗MalfunctionApr 9, 2021Defective Device; Defective Device
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 002620 AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 ML BLEW UP AND FAILED WHILE CONNECTED TO A PATIENT. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11646024 ↗
Other HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) devices
- Fisher & Paykel Healthcare PT101USFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)2 recalls5 deaths1,068 reports
- HUDSON RCI IPN913776Teleflex Incorporated · HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)436 reports
- F&P Optiflow+ OPT944Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)5 deaths392 reports
- Fisher & Paykel Healthcare PT100USFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)2 recalls59 reports
- MR850 MR850JHUFisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)93 reports
- HUDSON RCI HUD42500Medline Industries, Inc. · HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)87 reports
- F&P Optiflow Junior 2 OJR412Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)80 reports
- F&P Airvo 900PT561Fisher & Paykel Healthcare Limited · Humidifier, Respiratory Gas, (Direct Patient Interface)1 death56 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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