AirLife 3D0868Recalls & reported problems
Carefusion Corporation · Airlife™ Nebulizer Cap · Class 2
All models of AirLife (23)
Data updated Oct 16, 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 10885403180477), received between Mar 29, 2019 and Apr 23, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (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 16, 2026.
Most reported problems
Device problems
- Connection Problem1
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2021Defective Component; Defective Component
THE CUSTOMER REPORTED A CLOGGED NEBULIZER CAP THAT WOULDN'T NEBULIZE, AND APPARENTLY A COUPLE OTHERS HAVE BEEN REPORTED AS BEING SLUGGISH IN TERMS OF AEROSOL OUTPUT/SPUTTERING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11721220 ↗MalfunctionMar 29, 2019Connection Problem; Connection Problem
CUSTOMER REPORTED: AS PER RT, SUPPLIES FOR HIGH HUMIDITY FACE MASK OXYGEN DELIVERY REQUIRED FOR TREATMENT. AIRLIFE NEBULIZER CAP REQUIRED FOR TREATMENT, RETRIEVED WITH STERILE WATER BOTTLE. GIVEN TO RT. RT INFORMED STAFF THAT SUPPLIES DID NOT FIT TOGETHER. SECOND BOTTLE RETRIEVED. STILL DID NOT FIT. SECOND AIRLIFE NEBULIZER CAP RETRIEVED, ALSO DID NOT FIT. STAFF HAD TO GO TO FOR A THIRD AIRLIFE NEBULIZER CAP AND STERILE WATER BOTTLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8466073 ↗
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 HUD05014Medline Industries, Inc. · Nebulizer (direct patient interface)6 reports
- HUDSON RCI IPN049808Teleflex Incorporated · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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