McKesson 32642Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20612479203376), received between Jun 27, 2024 and Dec 10, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K091272, K926055); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2024Electrical /Electronic Property Problem; Mechanical Problem; Electrical /Electronic Property Problem; Mechanical Problem

  IT WAS REPORTED THAT THE UNIT WAS NOT WORKING AND OVERHEATED THE NEBULIZER MACHINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20897852 ↗
• MalfunctionJul 12, 2024Insufficient Flow or Under Infusion; Incomplete or Inadequate Connection; Insufficient Flow or Under Infusion; Incomplete or Inadequate Connection

  IT WAS REPORTED, DURING PATIENT USE, THE MEDICINE BUBBLED INSIDE THE CUP BUT DID NOT MIST OUT OF THE CUP. IT WAS ADDITIONALLY REPORTED, IT APPEARED TO NOT TO BE SITTING PROPERLY. THE EVENT OCCURRED DURING HOME USE; THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19735600 ↗
• MalfunctionJun 27, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED, THE SOLUTION FOR THE NEBULIZER INHALATION WAS NOT DISSIPATING FOR PROPER ADMINISTRATION FOR THE PATIENT.THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19629675 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091272, K926055. One submission often covers many models, so check the product and lot details in each record.

• Z-1058-2019 · Aug 29, 2018 · Terminated
  Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor system intended to provide a source of compress