Medline HCS70004Recalls & reported problems
Medline Industries, Inc. · COMPRESSOR,NEBULIZER,AEROMIST COMPACT · Class 2
Quick summary
This Medline AeroMist Compact nebulizer compressor is a portable air compressor used for breathing treatments. Many of its 1,150 reports describe no flow, restricted flow and pressure problems, and some describe loud noise. Recent reports describe overheating and a tube blowing off during use. The reports include no deaths and 69 injuries. No recalls name this device. Reports rose from 38 in the previous 12 months to 1,073 in the last 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 386
- Deaths reported
- 0
- Injuries reported
- 67
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 386 adverse event reports that list this exact device (DI 00884389106870), received between Apr 29, 2019 and Sep 30, 2026 — classified as 67 injuries, 317 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (81 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Infusion or Flow Problem81
- No Flow30
- Restricted Flow rate30
- Gas Output Problem27
- Pressure Problem25
- Noise, Audible24
- Decrease in Pressure23
- Failure to Deliver19
Patient problems
- No Clinical Signs, Symptoms or Conditions294
- Insufficient Information36
- Dyspnea22
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available19
- Cough5
- Wheezing4
- Asthma2
- Unspecified Respiratory Problem2
Recent adverse event reports
The 25 most recent of 386 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Overheating of Device; Failure to Power Up; Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953310 ↗MalfunctionSep 30, 2026Decrease in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952477 ↗MalfunctionSep 30, 2026Overheating of Device; Improper Flow or Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951354 ↗MalfunctionSep 30, 2026Contamination; Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951328 ↗MalfunctionSep 30, 2026Power Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951136 ↗MalfunctionSep 30, 2026Gas Output Problem; Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951088 ↗MalfunctionSep 30, 2026Failure to Deliver; Noise, Audible
Patient problems: Dyspnea
MAUDE report 50949971 ↗MalfunctionSep 30, 2026Infusion or Flow Problem; Noise, Audible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948874 ↗MalfunctionSep 30, 2026Mechanical Jam; Key or Button Unresponsive/not Working
It was reported that "The power button not working. It feels compressed down and cannot be pressed to turn on."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947555 ↗MalfunctionSep 30, 2026Failure to Power Up
It was reported that the device no longer turns on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946730 ↗MalfunctionSep 30, 2026Decrease in Pressure
This VMSR report summarizes 3 malfunction events that occurred during Q1 2023 (January 1, 2023, through March 31, 2023). The account reported that three compressors were not misting due to low pressure. The reported issue involved devices associated with serial numbers (b)(6). The affected devices were requested for return evaluation. Replacement units were issued for the affected devices. No patient age, weight, sex, race, or ethnicity information was available. No patient or user injuries were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946702 ↗MalfunctionSep 30, 2026Restricted Flow rate
This VMSR report summarizes 2 malfunction events that occurred during Q3 2025 (July 1, 2025, through September 30, 2025). The account reported that two HCS70004RD nebulizers, identified by Serial Numbers (b)(6), were not working as intended. The customer requested replacement of both devices; however, no specific description of the malfunction was initially provided. Additional information was requested to further characterize the reported issue, and the affected devices were returned for evaluation. The customer indicated that the devices were believed to be covered under a five-year warranty. No patient age, weight, sex, race, or ethnicity information was available. No patient or user injuries were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946458 ↗MalfunctionSep 30, 2026Crack; Incomplete or Inadequate Connection
It was reported that the tubing is cracked and cannot connect securely.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945896 ↗MalfunctionSep 30, 2026No Flow
It was reported that "NO STEAM OR NOTHING COMING" and "MAKES NOISE BUT NOT WORKING".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945754 ↗MalfunctionSep 30, 2026Failure to Power Up; Detachment of Device or Device Component
It was reported that "the unit will not turn on and there's so much pressure that it's making the hose pop off."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945594 ↗MalfunctionSep 30, 2026Infusion or Flow Problem
The report states, "Customer explained that the nebulizer stopped misting. They have completed all troubleshooting. Customer needs twice daily."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944758 ↗MalfunctionSep 30, 2026Loose or Intermittent Connection; Noise, Audible
The report states, "Customer explained that the unit when started is very loud like a hammering sound. Then the sound slowing goes away and something inside is loose.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944451 ↗MalfunctionSep 29, 2026Restricted Flow rate; Mechanical Problem; No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938674 ↗MalfunctionSep 29, 2026Break; Detachment of Device or Device Component; No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938253 ↗MalfunctionSep 29, 2026Output Problem; Noise, Audible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937395 ↗MalfunctionSep 29, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937201 ↗MalfunctionSep 29, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937069 ↗MalfunctionSep 29, 2026Mechanical Problem; Output below Specifications
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936110 ↗MalfunctionSep 29, 2026Restricted Flow rate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935317 ↗MalfunctionSep 29, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933271 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.