MEDLINE HCS4483Recalls & reported problems
Medline Industries, Inc. · NEBULIZER,KIT,T-MOUTHPIECE,6RESER,7TUB · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10080196715541), received between Apr 8, 2024 and Feb 2, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (2 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash2
- Fluid/Blood Leak1
- Gas Output Problem1
- Improper Flow or Infusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2026Fluid/Blood Leak; Gas Output Problem; Leak/Splash
ACCORDING TO THE FACILITY, "THE NEBULIZERS DO NOT PRODUCE AN AEROSOL AND LEAK OUT THE BOTTOM, DESPITE CHANGING THE NEBULIZER EVERY SINGLE TREATMENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24241258 ↗InjuryApr 16, 2024Leak/Splash; Leak/Splash
ACCORDING TO THE CUSTOMER, SHE RECEIVED A NEW MOUTHPIECE AND WHEN USING IT, WAS "DRIPPING CLEAR FLUID" FROM THE CAP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19116504 ↗InjuryApr 8, 2024Improper Flow or Infusion; Improper Flow or Infusion
ACCORDING TO THE CUSTOMER, DUE TO THE NEBULIZER "NEVER" WORKING HER HUSBAND HAS BEEN WITHOUT MEDICATION FOR "AWHILE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19068050 ↗
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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