DeVilbiss 525DS-QRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885304009689), received between Jul 28, 2022 and Sep 6, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Low Readings” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Nov 18, 2022Open, Classified

   The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life, and the need for maintenance to certain components.

   Z-0724-2023 · Root cause: Labeling False and Misleading · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2022No Flow; No Flow

  DEVILBISS HEALTHCARE WAS NOTIFIED BY AN AUTHORIZED SERVICE CENTER OF A COMPLAINT INVOLVING AN OXYGEN CONCENTRATOR WITH A COMPLAINT OF "NO O2 AT ALL." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE ROOT CAUSE OF THE NO O2 IS SHIPPING DAMAGE WHICH CAUSED THE TUBING TO BECOME DISCONNECTED FROM THE FLOW METER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15361622 ↗
• MalfunctionJul 28, 2022Low Readings; Low Readings

  DURING A RETROSPECTIVE COMPLAINT REVIEW, DEVILBISS HEALTHCARE IDENTIFIED AN OXYGEN CONCENTRATOR WITH COMPLAINT OF "LOW O2 PURITY." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. DEVILBISS EVALUATED THE UNIT AND DETERMINED THAT THE ROOT CAUSE OF THE CONDITION WAS NORMAL WEAR OF THE SIEVE BEDS AND COMPRESSOR CUP SEALS, WHICH WERE REPLACED. THE POWER LOSS ALARM WAS ALSO FOUND TO BE NOT OPERATING TO SPECIFICATION, AND THE PC BOARD WAS ALSO REPLACED. DEVILBISS IMPLEMENTED A CAPA FOR THE PC BOARD POWER LOSS ALARM ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15120668 ↗

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