OxyGo 1050Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817131020100), received between Mar 25, 2025 and Mar 25, 2025 — classified as 1 malfunction.

1 other recall cover devices cleared under the same FDA submission (K032818); 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.

• MalfunctionMar 25, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT EXPLAINED THAT THEY WERE HOSPITALIZED BECAUSE A PART OF THEIR OXYGEN UNIT BROKE, LEAVING THEM WITHOUT OXYGEN AT HOME. THE UNIT STOPPED WORKING, AND DUE TO A PREVIOUS DIAGNOSIS OF PULMONARY EMBOLISM, THE PATIENT COULDN'T BREATHE ON THEIR OWN. THEY HAD NO OTHER SOURCE OF OXYGEN BECAUSE THEIR BACKUP UNIT HAD MALFUNCTIONED THE DAY BEFORE. CONSEQUENTLY, THE PATIENT HAD TO SPEND TWO EXTRA NIGHTS IN THE HOSPITAL UNTIL A REPLACEMENT UNIT WAS DELIVERED.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD); Dyspnea

  MAUDE report 21688714 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032818. One submission often covers many models, so check the product and lot details in each record.

• Z-1368-05 · Aug 1, 2005 · Terminated
  Portable Oxygen Generator