AirLife™ FN2444Recalls & reported problems

Airlife · AirLife™ Misty Fast™ Small Volume Nebulizer With 7 foot (2.1 m) Crush Resistant Oxygen Tubing and Pediatric Aerosol Mask (Under-the-Chin Style) · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190752117648), received between Oct 4, 2024 and Oct 4, 2024 — classified as 1 malfunction.

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 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 4, 2024
TUBING IN PACKAGE IS COVERED IN A "STICKY" SUBSTANCE. THERE WAS AN UNKNOWN CHEMICAL ON TUBING THAT COULD CAUSE UNKNOWN REACTIONS WITH MEDICATION, CAUSING UNKNOWN COMPLICATIONS. PROCEDURE WAS COMPLETED WITH A DIFFERENT NEBULIZER TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20368420 ↗

Device details

UDI-DI	`10190752117648`
Brand	AirLife™
Model	FN2444
Company	Airlife
Product code	CAF · Nebulizer (direct patient interface)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 24, 2025

Device type (GMDN): Therapeutic agent nebulizer, benchtop

An assembly of devices intended to be used in the home and clinical to aerosolize medication/fluids, by non-heat-dependent means (i.e., not a vaporizer), for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator (ultrasonic and/or compressor jet type), a reservoir, and a nebulizing chamber where the nebulization of the medicine usually occurs. Disposable devices (e.g., tubing, mask, mouthpiece) are attached to the device for inhalation. It is designed to be placed on a benchtop/flat surface during use.

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All Nebulizer (direct patient interface) devices →

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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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