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Medline HCS70004CRecalls & reported problems

Medline Industries, Inc. · COMPRESSOR,AEROMIST COLORS ,CHARCOAL · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888277415044), received between Dec 3, 2024 and Sep 24, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Output Problem” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Output Problem2
  • Insufficient Flow or Under 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.

  • MalfunctionSep 24, 2026Output Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50890528 ↗
  • MalfunctionMay 15, 2026Output Problem

    IT WAS REPORTED THAT THE NEBULIZER IS NOT BLOWING AIR. THE ITEM IS BRAND NEW.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25194106 ↗
  • InjuryDec 3, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

    ACCORDING TO THE CUSTOMER, THE NEBULIZER WAS "NOT MISTING" CAUSING HER TO MISS HER "IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE" MEDICATIONS FOR "ABOUT 1 WEEK".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20832926 ↗

Other Compressor, air, portable devices

All Compressor, air, portable devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.