DeVilbiss 1025KSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00853040224734), received between Oct 19, 2023 and Jun 15, 2026 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (3 reports).

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. Mar 9, 2023Open, Classified

   The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.

   Z-1558-2023 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2026Use of Device Problem

  DRIVE MEDICAL WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY FRANCE ANSM THAT STATED THAT THE END USER BURNED HERSELF WHILE SMOKING DURING USE OF SUPPLEMENTAL OXYGEN WITH HER NON-INVASIVE VENTILATION MASK. THE END USER REFUSED MEDICAL INTERVENTION AND WAS EDUCATED BY THE PROVIDER ON THE SAFE USE OF SUPPLEMENTAL OXYGEN. THE DEVICE CONTAINS SEVERAL WARNINGS AGAINST SMOKING DURING USE, BOTH ON THE PRODUCT ITSELF AND IN INSTRUCTIONS FOR USE. THE ON-PRODUCT WARNINGS INCLUDE A LARGE, CLEAR "NO SMOKING" ICON, AND A CLEAR "NO OPEN FLAME" ICON AS WELL. THE INSTRUCTIONS FOR USE WARN AGAINST SMOKING DURING USE IN SEVERAL PLACES, IN SEVERAL LANGUAGES, INCLUDING THE FOLLOWING VERBIAGE: "OXYGEN CAUSES RAPID BURNING. DO NOT SMOKE WHILE YOUR OXYGEN CONCENTRATOR IS OPERATING, OR WHEN YOU ARE NEAR A PERSON UTILIZING OXYGEN THERAPY. SMOKING DURING OXYGEN THERAPY IS DANGEROUS AND IS LIKELY TO RESULT IN FACIAL BURNS OR DEATH. DO NOT ALLOW SMOKING WITHIN THE SAME ROOM WHERE THE OXYGEN CONCENTRATOR OR ANY OXYGEN CARRYING ACCESSORIES ARE LOCATED. IF YOU INTEND TO SMOKE, YOU MUST ALWAYS TURN THE OXYGEN CONCENTRATOR OFF, REMOVE THE CANNULA AND LEAVE THE ROOM WHERE EITHER THE CANNULA OR MASK

  Patient problems: Burn(s)

  MAUDE report 25502952 ↗
• InjuryJan 7, 2026Use of Device Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE PROVIDER WHO REPORTED THE END USER WAS SMOKING WHILE USING THE DEVICE. THE END USER WAS HOSPITALIZED WITH BURNS TO HIS FACE AND SINCE HAS BEEN RELEASED FROM THE HOSPITAL. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DEVILBISS HEALTHCARE WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE DEVICE CONTAINS SEVERAL WARNINGS AGAINST SMOKING DURING USE, BOTH ON THE PRODUCT ITSELF AND IN INSTRUCTIONS FOR USE. THE ON-PRODUCT WARNINGS INCLUDE A LARGE, CLEAR "NO SMOKING" ICON, AND A CLEAR "NO OPEN FLAME" ICON AS WELL. THE INSTRUCTIONS FOR USE WARN AGAINST SMOKING DURING USE IN SEVERAL PLACES, IN SEVERAL LANGUAGES, INCLUDING THE FOLLOWING VERBIAGE: "OXYGEN CAUSES RAPID BURNING. DO NOT SMOKE WHILE YOUR OXYGEN CONCENTRATOR IS OPERATING, OR WHEN YOU ARE NEAR A PERSON UTILIZING OXYGEN THERAPY. SMOKING DURING OXYGEN THERAPY IS DANGEROUS AND IS LIKELY TO RESULT IN FACIAL BURNS OR DEATH. DO NOT ALLOW SMOKING WITHIN THE SAME ROOM WHERE THE OXYGEN CONCENTRATOR OR ANY OXYGEN CARRYING ACCESSORIES ARE LOCATED. IF YOU INTEND TO SMOKE, YOU MUST ALWAYS TURN THE OXYGEN CONCENTRATOR OFF, REMOVE

  Patient problems: Burn(s)

  MAUDE report 23992172 ↗
• DeathOct 19, 2023Use of Device Problem; Use of Device Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BEING USED BY THE PATIENT WHILE SMOKING. THE PATIENT REPORTEDLY RECEIVED SEVERE BURNS AND EXPIRED ON (B)(6) 2023. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE CONTAINS SEVERAL WARNINGS AGAINST SMOKING DURING USE, BOTH ON THE PRODUCT ITSELF AND IN THE INSTRUCTIONS FOR USE. THE ON-PRODUCT WARNINGS INCLUDE A LARGE, CLEAR "NO SMOKING" ICON, AND A CLEAR "NO OPEN FLAME" ICON AS WELL. THE INSTRUCTIONS FOR USE WARN AGAINST SMOKING DURING USE IN SEVERAL PLACES, IN SEVERAL LANGUAGES, INCLUDING THE FOLLOWING VERBIAGE: "OXYGEN CAUSES RAPID BURNING. DO NOT SMOKE WHILE YOUR OXYGEN CONCENTRATOR IS OPERATING, OR WHEN YOU ARE NEAR A PERSON UTILIZING OXYGEN THERAPY. SMOKING DURING OXYGEN THERAPY IS DANGEROUS AND IS LIKELY TO RESULT IN FACIAL BURNS OR DEATH. DO NOT ALLOW SMOKING WITHIN THE SAME ROOM WHERE THE OXYGEN CONCENTRATOR OR ANY OXYGEN CARRYING ACCESSORIES ARE LOCATED. IF YOU INTEND TO SMOKE, YOU MUST ALWAYS TURN THE OXYGEN CONCENTRATOR OFF, REMOVE THE CANNULA AND LEAVE THE ROOM WHERE EITHER THE CANNULA OR MASK OR THE OXYGEN CONCENTRATOR IS LOCATED. IF UNABLE TO LEAVE THE ROOM, YOU MUST WAIT 10 MINUT

  Patient problems: Burn(s)

  MAUDE report 17968521 ↗

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-0724-2023 · Nov 18, 2022 · Open, Classified
  DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q