Medline HCSFISHNEBRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884389197455), received between Mar 12, 2024 and Sep 28, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Output Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K031413); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925997 ↗
• MalfunctionMay 9, 2026Output Problem; Excessive Heating

  IT WAS REPORTED ON (B)(6) THAT THE NEBULIZER WAS NOT CONVERTING MEDICATION INTO MIST AND APPEARED TO OVERHEAT DURING OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25132851 ↗
• MalfunctionMay 14, 2025Output Problem; Output Problem

  ACCORDING TO THE CUSTOMER THE NEBULIZER IS NOT DISPENSING THE MEDICATION, AND THE USER HAS MISSED THEIR BREATHING TREATMENT OF "PULMICORT".

  Patient problems: Dyspnea

  MAUDE report 22018887 ↗
• InjuryFeb 18, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CUSTOMER STARTING ON 1/21, THE NEBULIZER STOPPED WORKING.

  Patient problems: Insufficient Information

  MAUDE report 21398105 ↗
• MalfunctionJan 7, 2025Infusion or Flow Problem; Infusion or Flow Problem

  MEDICATION IS NOT COMING OUT OF MACHINE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21093566 ↗
• InjuryMar 12, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CUSTOMER ON 02/14/24 THEY "POURED ONE VIAL OF ALBUTEROL AND THE NEBULIZER WAS ON FOR ABOUT 3 MINUTES WHEN IT STOPPED WORKING, IT STARTED MAKING A LOUD CLUNK NOISE AND IT STOPPED MISTING".

  Patient problems: Cough

  MAUDE report 18888653 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031413. One submission often covers many models, so check the product and lot details in each record.

• Z-1720-2015 · Apr 20, 2015 · Terminated
  Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy that converts liquid medicine into a fine mist that is easily inhaled.