Airlife™ Sterile water for Inhalation, USP 2000 ml 2D0737Recalls & reported problems
Airlife · Sterile Water for inhalation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10190752196438), received between Nov 2, 2023 and Nov 2, 2023 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (6 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.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem6
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 2, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE WAS RESIDUE FOUND OR LEFT IN THE 2D0737 - WATER STERILE F/INHALATION 2000ML 6/CS WATER CHAMBER DURING PATIENT USE. IT WAS ALSO MENTIONED THAT THE RESIDUE WAS FOUND TO RANGE ANYWHERE FROM 6¿28 DAYS OF USE WITH THE WATER CHAMBER. THE PATIENTS ALL REMAINED STABLE WITH NO ADVERSE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18062235 ↗MalfunctionNov 2, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE WAS RESIDUE FOUND OR LEFT IN THE 2D0737 - WATER STERILE F/INHALATION 2000ML 6/CS WATER CHAMBER DURING PATIENT USE. IT WAS ALSO MENTIONED THAT THE RESIDUE WAS FOUND TO RANGE ANYWHERE FROM 6¿28 DAYS OF USE WITH THE WATER CHAMBER. THE PATIENTS ALL REMAINED STABLE WITH NO ADVERSE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18062223 ↗MalfunctionNov 2, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE WAS RESIDUE FOUND OR LEFT IN THE 2D0737 - WATER STERILE F/INHALATION 2000ML 6/CS WATER CHAMBER DURING PATIENT USE. IT WAS ALSO MENTIONED THAT THE RESIDUE WAS FOUND TO RANGE ANYWHERE FROM 6¿28 DAYS OF USE WITH THE WATER CHAMBER. THE PATIENTS ALL REMAINED STABLE WITH NO ADVERSE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18062212 ↗MalfunctionNov 2, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE WAS RESIDUE FOUND OR LEFT IN THE 2D0737 - WATER STERILE F/INHALATION 2000ML 6/CS WATER CHAMBER DURING PATIENT USE. IT WAS ALSO MENTIONED THAT THE RESIDUE WAS FOUND TO RANGE ANYWHERE FROM 6¿28 DAYS OF USE WITH THE WATER CHAMBER. THE PATIENTS ALL REMAINED STABLE WITH NO ADVERSE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18062201 ↗MalfunctionNov 2, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE WAS RESIDUE FOUND OR LEFT IN THE (B)(6) - WATER STERILE F/INHALATION 2000ML 6/CS WATER CHAMBER DURING PATIENT USE. IT WAS ALSO MENTIONED THAT THE RESIDUE WAS FOUND TO RANGE ANYWHERE FROM 6¿28 DAYS OF USE WITH THE WATER CHAMBER. THE PATIENTS ALL REMAINED STABLE WITH NO ADVERSE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18062181 ↗MalfunctionNov 2, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE WAS RESIDUE FOUND OR LEFT IN THE (B)(6) - WATER STERILE F/INHALATION 2000ML 6/CS WATER CHAMBER DURING PATIENT USE. IT WAS ALSO MENTIONED THAT THE RESIDUE WAS FOUND TO RANGE ANYWHERE FROM 6¿28 DAYS OF USE WITH THE WATER CHAMBER. THE PATIENTS ALL REMAINED STABLE WITH NO ADVERSE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18062178 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page