Medline HCS70004RDRecalls & reported problems
Medline Industries, Inc. · COMPRESSOR, REUS AND DISP NEBULIZER KIT · Class 2
Quick summary
This Medline nebulizer compressor has 228 adverse event reports, including 203 malfunctions, 24 injuries and no deaths. The reports mostly describe the unit stopping or weakening its mist, airflow being blocked or restricted, and the unit failing to power up. No recalls name this device. Reports rose from 21 in the previous 12 months to 198 in the most recent 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
- 108
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 00888277415068), received between Sep 15, 2022 and Sep 30, 2026 — classified as 25 injuries, 83 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (22 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 Problem22
- Restricted Flow rate10
- Failure to Deliver9
- No Flow8
- Noise, Audible8
- Appropriate Device Problem Term/Code Not Available6
- Detachment of Device or Device Component5
- Gas Output Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions80
- Dyspnea9
- Insufficient Information8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Unspecified Respiratory Problem3
- Asthma2
- Chronic Obstructive Pulmonary Disease (COPD)2
- Cough2
Recent adverse event reports
The 25 most recent of 108 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Restricted Flow rate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954859 ↗MalfunctionSep 30, 2026Restricted Flow rate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953899 ↗MalfunctionSep 30, 2026Infusion or Flow Problem
Patient problems: Unspecified Respiratory Problem
MAUDE report 50953197 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953136 ↗MalfunctionSep 30, 2026Loose or Intermittent Connection; Pressure Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952882 ↗MalfunctionSep 30, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952302 ↗MalfunctionSep 30, 2026Insufficient Flow or Under Infusion; Detachment of Device or Device Component; No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951395 ↗MalfunctionSep 30, 2026Mechanical Jam; No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949623 ↗MalfunctionSep 30, 2026Gas Output Problem
It was reported that the device was "NOT PUTTING OUT ANY AIR, THE MEDICINE IS NOT MOVING AT, NO AIR COMES OUT OF THE MOUTHPIECE. IT IS ON, IT IS RUNNING, IT IS NOT PUSHING OUT ENOUGH AIR TO BE EFFECTIVE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947535 ↗MalfunctionSep 30, 2026Restricted Flow rate
It was reported that "TAKES AT LEAST HOUR TO GO THROUGH THE SALINE; WHEN IT SHOULD ONLY TAKE BETWEEN 20-30 MINUTES" and "FEELS LIKE IT NOT WORK."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946108 ↗MalfunctionSep 30, 2026Restricted Flow rate
This VMSR report summarizes 5 malfunction events that occurred during Q3 2023 (July 1, 2023, through September 30, 2023). The account reported that five HCS70004RD nebulizers experienced low flow output and failed to meet performance expectations. The reported issue involved devices associated with lot/serial numbers (b)(6). Replacement units were requested. No patient age, weight, sex, race, or ethnicity information was available. No patient or user injuries were reported. The devices were returned for evaluation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945342 ↗MalfunctionSep 29, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937662 ↗MalfunctionSep 29, 2026Vibration; Failure to Deliver; Noise, Audible
Patient problems: Chronic Obstructive Pulmonary Disease (COPD)
MAUDE report 50937646 ↗MalfunctionSep 29, 2026Restricted Flow rate; Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937408 ↗MalfunctionSep 29, 2026Power Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934019 ↗MalfunctionSep 29, 2026Mechanical Problem; Insufficient Flow or Under Infusion; Noise, Audible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933338 ↗MalfunctionSep 29, 2026Fluid/Blood Leak; Output below Specifications
It was reported that "CORDS ARE LEAKING AND THE POWER IS WEAKER AND CAN BE HEARD THAT IT IS NOT AS STRONG."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931974 ↗MalfunctionSep 29, 2026Decrease in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931856 ↗MalfunctionSep 29, 2026Power Problem
The report states that the device does not power on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931063 ↗MalfunctionSep 28, 2026Power Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926516 ↗MalfunctionSep 28, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926491 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924346 ↗MalfunctionSep 28, 2026Crack; Material Fragmentation
Patient problems: Cancer
MAUDE report 50924283 ↗MalfunctionSep 28, 2026Decrease in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923978 ↗MalfunctionSep 28, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923711 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.