McKesson 146-525DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10612479248158), received between Oct 5, 2023 and Oct 5, 2023 — classified as 1 malfunction.

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

3 other recalls cover devices cleared under the same FDA submission (K071397); 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.

• MalfunctionOct 5, 2023Temperature Problem; Temperature Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT INVOLVING AN OXYGEN CONCENTRATOR BY AN END USER'S SON, WHO STATED THERE WAS AN "EXPLOSION AND BLACK SMOKE." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. DEVILBISS IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO GAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AND RETRIEVE THE DEVICE FOR EXAMINATION. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17878303 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071397. One submission often covers many models, so check the product and lot details in each record.

• Z-1727-2025 · Apr 11, 2025 · Open, Classified
  iGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.
• Z-1558-2023 · Mar 9, 2023 · Open, Classified
  DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
• Z-0724-2023 · Nov 18, 2022 · Open, Classified
  DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q