AirLife™ 002438Recalls & reported problems
Vyaire Medical, Inc. · AirLife™ Misty Max 10™ Nebulizer With 7 foot (2.1 m) Crush Resistant Oxygen Tubing, Baffled Tee Adapter (22 mm I.D./22 mm O.D.), Mouthpiece and 6 inch (15 cm) Flextube · Class 2
All models of AirLife (25)
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 10190752114869), received between Apr 27, 2020 and Dec 10, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Defective Component” (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
- Defective Component1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE PATIENT CALLED FOR ASSISTANCE, EXTREMELY SOB AND WHEEZING. SHE ASKED FOR A MASK TREATMENT, WHICH IS ADMINISTERED VIA NEBULIZER. WRITER ATTEMPTED TO ADMINISTER REQUESTED MEDICATION BUT WAS UNABLE TO DO SO. WRITER CHECKED NEBULIZER COMPONENTS AND ENSURED THAT DIFFUSER WAS LOCKED PROPERLY IN PLACE THEN REATTEMPTED TO ADMINISTER THE MEDICATION. WRITER UNABLE TO GET FLOW METER ABOVE 4L. FLOW METER CHANGED OUT WITH NO POSITIVE RESULT. ENTIRE NEBULIZER SYSTEM CHANGED OUT AND PLUGGED INTO O2 TANK. ADMINISTRATION SUCCESSFUL! FLOW METERS TESTED POST ADMINISTRATION. TESTING CONFIRMED THAT NEBULIZER SET (1ST USED) MALFUNCTIONED AND CHANGE OUT WAS NECESSARY. PCM AND ATTENDING NOTIFIED OF EVENT. MALFUNCTIONING EQUIPMENT SENT DOWN TO PURCHASING WITH PRODUCT COMPLAINT FORM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20897918 ↗MalfunctionApr 27, 2020Defective Component; Defective Component
THE CUSTOMER REPORTED THAT THE AIRLIFE MISTY MAX 10 NEBULIZER WOULD NOT MIST. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10001964 ↗
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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