Medline HCS60004Recalls & reported problems
Medline Industries, Inc. · COMPRESSOR,NEBULIZER,AEROMIST PLUS · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884389104774), received between Apr 1, 2025 and Sep 30, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
- Infusion or Flow Problem1
- Noise, Audible1
- Pressure Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Cough1
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Infusion or Flow Problem; Noise, Audible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951066 ↗MalfunctionSep 28, 2026Pressure Problem
This summary report covers one malfunction event reported to Medline between July 1 and September 30, 2023. This VMSR summarizes one malfunction event involving two Medline nebulizer compressors (catalog number HCS60004). The account reported that the units had stopped working. No devices were returned, and no samples or photographs were available for evaluation; therefore, the reported malfunction could not be confirmed and the cause could not be established. No patient information was available. No patient or user injuries were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915179 ↗InjuryApr 23, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER WHEN SHE PLUGS IN THE MACHINE, IT MAKES THE NORMAL NOISE BUT DOES NOT MIST. THE CUSTOMER IS STILL COUGHING SINCE SHE IS NOT ABLE TO RECEIVE HER ALBUTEROL.
Patient problems: Cough
MAUDE report 21894948 ↗InjuryApr 1, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER ON 3/4, THE MEDICATION WAS NOT COMING OUT OF BTHE ATTACHMENT SO NOTHING CAN BE INHALED AND THE USER WAS UNABLE TO RECEIVE HER MEDICATION.
Patient problems: Insufficient Information
MAUDE report 21746669 ↗
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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