DeVilbiss 535C-D-870Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885304020936), received between Jul 10, 2025 and Jul 10, 2025 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K053240); 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 16, 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.

• MalfunctionJul 10, 2025Mechanical Problem; Mechanical Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CYLINDER BY THE PROVIDER, WHO REPORTED THAT WHILE BEING FILLED ON AN IFILL DEVICE, THE CYLINDER BROKE APART AT THE NIPPLE ADAPTER AND DISCONNECTED. THE CYLINDER, HAVING BEEN UNDER PRESSURE, PROPELLED ITSELF ACROSS THE ROOM. THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, SERIOUS INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. DEVILBISS HEALTHCARE WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470057 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K053240. One submission often covers many models, so check the product and lot details in each record.

• Z-0038-2007 · Aug 24, 2006 · Terminated
  DeVilbiss iFill Personal Oxygen Station model number 535D.