Medline HCS2GORecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884389159975), received between Nov 25, 2025 and Nov 25, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Connection Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K031413); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Connection Problem; Connection Problem

  ACCORDING TO THE CUSTOMER, "CUSTOMER JUST UNBOXED THE UNIT (NEBULIZER) AND THE CORD DOES NOT CONNECT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649941 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031413. One submission often covers many models, so check the product and lot details in each record.

• Z-1720-2015 · Apr 20, 2015 · Terminated
  Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy that converts liquid medicine into a fine mist that is easily inhaled.