AirLife™ Misty Max 10™ Nebulizer With 7 foot (2.1 m) 002433Recalls & reported problems
Vyaire Medical, Inc. · AirLife™ Misty Max 10™ Nebulizer With 7 foot (2.1 m) Crush Resistant Oxygen Tubing with Adult Aerosol Mask · Class 2
Data updated Oct 18, 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 10190752114821), received between Dec 30, 2020 and Nov 15, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination” (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.
Reports received per month
Most reported problems
Device problems
- Contamination1
- Defective Component1
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.
MalfunctionNov 15, 2023Contamination; Contamination
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE TUBING WAS VERY STICKY AND GREASY TO TOUCH. THE MASK WAS USED BY A PATIENT WITH NO INCIDENCE OBSERVED DURING TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18145402 ↗MalfunctionDec 30, 2020Defective Component; Defective Component
THE CUSTOMER REPORTED THAT THE BLUE CENTER PIECE OF THE AIRLIFE MISTY-NEB MEDICATION NEBULIZERS HAS BEEN FLYING OFF. IT IS ALSO REPORTED THAT MEDICATION TIME HAS BEEN GOING THROUGH IN 12 MINUTES. HOWEVER, THERE HAS BEEN NO INJURY OR HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11097809 ↗
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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