DeVilbiss 7305D-D-EXFRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885304008866), received between Aug 16, 2022 and Aug 16, 2022 — classified as 1 malfunction.

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

3 other recalls cover devices cleared under the same FDA submission (K982304); 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.

• MalfunctionAug 16, 2022Suction Problem; Suction Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED BY AN OXYGEN SUPPLIER OF A COMPLAINT INVOLVING A DEVILBISS SUCTION UNIT STATING THAT THE UNIT IS "NOT SUCTIONING PROPERLY." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE DEVICE WAS RETURNED FOR EVALUATION. DEVILBISS EVALUATED THE UNIT AND DETERMINED THAT THE PRIMARY CAUSE WAS AN UMBRELLA VALVE BEING DISLODGED FROM THE COMPRESSOR CYLINDER, MANIFOLD, BROKEN/DAMAGED SUCTION GAUGE. DEVILBISS HAS AN ACTIVE CAPA ASSOCIATED WITH CYLINDER/VALVE COMPLAINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15234901 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K982304. One submission often covers many models, so check the product and lot details in each record.

• Z-2246-2016 · May 23, 2016 · Terminated
  DeVilbiss Model 7305P-D Powered Suction Unit
• Z-2319-2013 · Mar 7, 2013 · Terminated
  DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container
• Z-0863-2009 · Oct 27, 2008 · Terminated
  DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit. A portable, AC-powered or compressed air-powered suction pump. The device may include a microbial filter.