AirLife™ 002450Recalls & reported problems
Vyaire Medical, Inc. · AirLife™ Misty Max 10™ Nebulizer Medication System with Filter · Class 2
All models of AirLife (25)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10190752114944), received between May 12, 2022 and May 18, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (4 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/Splash4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING TREATMENT OF ALBUTEROL/PENTAMIDINE THE AIRLIFE MISTY MAX NEBULIZER HAD A MULTIPLE MEDICATION LEAK ISSUE DURING PATIENT USE. THE MEDICATION IS GETTING THROUGH THE MIDDLE FILTER ON THE DEVICE/TUBING AND POOLING. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14432053 ↗MalfunctionMay 18, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING TREATMENT OF ALBUTEROL/PENTAMIDINE THE AIRLIFE MISTY MAX NEBULIZER HAD A MULTIPLE MEDICATION LEAK ISSUE DURING PATIENT USE. THE MEDICATION IS GETTING THROUGH THE MIDDLE FILTER ON THE DEVICE/TUBING AND POOLING. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14432018 ↗MalfunctionMay 18, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING TREATMENT OF ALBUTEROL/PENTAMIDINE THE AIRLIFE MISTY MAX NEBULIZER HAD A MULTIPLE MEDICATION LEAK ISSUE DURING PATIENT USE. THE MEDS ARE GETTING THROUGH THE MIDDLE FILTER ON THE DEVICE/TUBING AND POOLING. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14432002 ↗MalfunctionMay 12, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING TREATMENT OF ALBUTEROL/PENTAMIDINE THE AIRLIFE MISTY MAX NEBULIZER HAD A MULTIPLE MEDICATION LEAK ISSUE DURING PATIENT USE. THE MEDS ARE GETTING THROUGH THE MIDDLE FILTER ON THE DEVICE/TUBING AND POOLING. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14382098 ↗
Other Nebulizer (direct patient interface) devices
- HUDSON RCI IPN049807Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)62 reports
- Circulaire™ 0330Sunmed, LLC · Nebulizer (Direct Patient Interface)1 recall0 reports
- I neb 00Respironics Respiratory Drug Delivery (Uk) Ltd · NEBULIZER (DIRECT PATIENT INTERFACE)3 deaths15 reports
- VixOne 0209Westmed, Inc. · Nebulizer (Direct Patient Interface)13 reports
- HUDSON RCI IPN040620Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)12 reports
- HUDSON RCI IPN049808Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)6 reports
- HUDSON RCI HUD05014Medline Industries, Inc. · Nebulizer (direct patient interface)6 reports
- VixOne 0210Westmed, Inc. · Nebulizer (Direct Patient Interface)5 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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