Medline HCS70004ADLTRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888277703752), received between Apr 11, 2024 and Sep 28, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916904 ↗
• MalfunctionAug 17, 2026Restricted Flow rate

  It was reported that nebulizer does not work properly as intended; there is no air that comes out of the product at all when turned on.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50275764 ↗
• MalfunctionMay 13, 2026Failure to Power Up

  IT WAS REPORTED THAT IT WILL NOT TURN ON AND MENTIONED UNSURE IF THE UNIT OVERHEATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163978 ↗
• InjuryApr 11, 2024Infusion or Flow Problem; Infusion or Flow Problem

  ACCORDING TO THE CUSTOMER, THE MEDICATION IN HIS NEBULIZER "BUBBLES" IN THE CHAMBER BUT IS NOT COMING OUT OF THE "MOUTHPIECE".

  Patient problems: Dyspnea

  MAUDE report 19088845 ↗