DeVilbiss 525KSRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885304000976), received between Dec 15, 2023 and Dec 17, 2025 — classified as 4 deaths, 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (5 reports).

3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• DeathDec 17, 2025Use of Device Problem; Use of Device Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR THAT WAS REPORTED BY A GERMAN SPECIALIST RETAILER, IN WHICH THE HUSBAND OF THE END USER STATED THAT THE END USER PASSED AWAY. THE END USER WAS SMOKING WHILE TAKING A BATH, AND THE NASAL CANNULA TUBING CAUGHT ON FIRE. THE HUSBAND STATED THAT AN AUTOPSY WAS COMPLETED AND THAT THE CAUSE OF DEATH APPEARS TO BE UNCLEAR. THE OXYGEN CONCENTRATOR WAS INSPECTED AT THE MANUFACTURER'S AUTHORIZED REPRESENTATIVE IN GERMANY. THE CAUSE OF THE FIRE WAS AN EXTERNAL IGNITION SOURCE THAT TRAVELED TO THE UNIT VIA THE OXYGEN TUBING. TRACES AND BURN MARKS FROM THE OXYGEN TUBING ARE VISIBLE ON THE FRONT OF THE HOUSING. THE UNIT'S FIRESTOP OPERATED PROPERLY TO EXTINGUISH THE FLAME AT THE UNIT'S FIRESTOP SLEEVE. THE DEALER REPORTED THAT THEY PROVIDED INITIAL TRAINING TO THE END USER UPON DELIVERY OF THE OXYGEN CONCENTRATOR. TWO FIRESTOP VALVES AND OXYGEN TUBING WERE PROVIDED, AND THE USER WAS INSTRUCTED ON THEIR USE. 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 FLAM

  Patient problems: Insufficient Information

  MAUDE report 23830079 ↗
• InjuryNov 19, 2025Device Alarm System; Device Alarm System

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE FRENCH REGULATORY AGENCY (ANSM), THAT DURING USE, THE OXYGEN CONCENTRATOR DID NOT ALARM, THE END USER'S OXYGEN SATURATION DROPPED TO 60%, AND THE END USER BECAME CYANOTIC. THE MEDICAL EMERGENCY SERVICE WAS CALLED TO ASSIST AND THE END USER'S OXYGEN SATURATION QUICKLY CORRECTED WHEN OXYGEN WAS PROVIDED. THE USER MANUAL CONTRAINDICATIONS STATE: "THE DEVICE IS NOT INTENDED TO BE LIFE SUPPORTING OR LIFE SUSTAINING. THE DEVILBISS 5 LITER OXYGEN CONCENTRATOR MAY BE CONTRAINDICATED IN PATIENTS AT RISK OF EXPERIENCING SERIOUS ADVERSE HEALTH CONSEQUENCES RESULTING FROM A TEMPORARY LOSS OF FUNCTION." DEVILBISS HEALTHCARE IS INVESTIGATING THE ISSUE AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23594380 ↗
• MalfunctionAug 7, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE FRENCH AGENCY (ANTADIR), WHICH REPORTED THAT THE CONCENTRATOR EMITTED BLACK SMOKE AND HAD EVIDENCE OF DEFORMATION TO THE CASING AT THE MAIN SOCKET, INCLUDING THE POWER CORD. THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, SERIOUS INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. DEVILBISS HEALTHCARE IS ATTEMPTING TO RETRIEVE THE UNIT FOR EVALUATION AND WILL FILE AN UPDATE WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737232 ↗
• InjuryJun 11, 2025Use of Device Problem; Use of Device Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE FRENCH REGULATORY AGENCY (ANSM) THAT AN END USER WAS SMOKING A CIGARETTE WHILE USING THE DEVICE AND BURNED THEIR NOSTRILS. IT IS UNKNOWN IF MEDICAL TREATMENT WAS REQUIRED FOR THE END USER. THERE WAS NO THERMAL DAMAGE TO THE DEVICE. 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 OR THE OXYGEN CO

  Patient problems: Burn(s)

  MAUDE report 22182959 ↗
• DeathMar 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE LOCAL AUTHORITIES REGARDING A FIRE THAT OCCURRED IN AN APARTMENT OF A NURSING HOME. THE RESIDENT WAS FOUND TO HAVE DIED IN THE FIRE. THE END USER WAS A KNOWN SMOKER. DRIVE DEVILBISS HEALTHCARE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO INSPECT THE DEVICE IN COOPERATION WITH THE LOCAL AUTHORITIES.

  Patient problems: Burn(s)

  MAUDE report 21586175 ↗
• MalfunctionOct 16, 2024Temperature Problem; Temperature Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE PROVIDER WHO STATED THAT THE DEVICE WAS SMOKING AND CAUGHT ON FIRE. THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. DEVILBISS HEALTHCARE IS IN THE PROCESS OF REQUESTING THE UNIT BE RETURNED FOR EVALUATION AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20466815 ↗
• InjuryOct 10, 2024Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A CONCENTRATOR BY THE PROVIDER WHO REPORTED THE DEVICE WAS ALARMING FOR LOW OXYGEN CONCENTRATION FOR TWO WEEKS. THE END USER WAS ADMITTED TO THE HOSPITAL. DEVILBISS HEALTHCARE IS IN THE PROCESS OF REQUESTING THE UNIT BE RETURNED FOR EVALUATION AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20422473 ↗
• DeathSep 27, 2024Mechanical Problem; Mechanical Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY A PROVIDER WHO STATED THAT THE DEVICE WAS ALARMING. THE DEVICE IS OVER TWO YEARS OLD AND WAS RETURNED TO THE PROVIDER WHO TESTED THE DEVICE AND FOUND THE DEVICE TO HAVE LOW OXYGEN CONCENTRATION. THE PROVIDER REPORTED THAT THE DEVICE WAS VISUALLY AND AUDIBLY ALARMING AS PER SPECIFICATION. ROUTINE SERVICE IS REQUIRED FOR THE PROPER FUNCTION OF THE DEVICE. THE DEVICE IS NOT A LIFE SUPPORTING OR LIFE SUSTAINING DEVICE. THE LAST END USER TO UTILIZE THE DEVICE WAS REPORTED TO HAVE PASSED AWAY. IT IS UNKNOWN IF THE DEVICE CAUSED OR CONTRIBUTED TO THE END USER'S DEATH. DEVILBISS HEALTHCARE WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20325253 ↗
• InjuryJul 5, 2024Use of Device Problem; Use of Device Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE PROVIDER WHO REPORTED THAT THE END USER WAS USING A GRINDER WHILE HAVING OXYGEN ON. THE END USER SUFFERED BURNS TO HIS NOSE. THE END USER WENT TO THE DOCTOR AND HAS NURSING CARE AT HOME. 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

  Patient problems: Burn(s)

  MAUDE report 19680361 ↗
• InjuryJun 26, 2024Use of Device Problem; Use of Device Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR BY THE FRENCH REGULATORY AGENCY (ANSM) THAT AN END USER WAS HOSPITALIZED AFTER RECEIVING BURNS TO HER FACE WHEN SHE WAS "PLAYING WITH A LIGHTER" AND THE CONCENTRATOR CAUGHT ON FIRE. 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, Y

  Patient problems: Burn(s)

  MAUDE report 19614801 ↗
• DeathDec 15, 2023Use of Device Problem; Use of Device Problem

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT BY THE FRENCH REGULATORY AGENCY IN WHICH THE END USER SMOKED CIGARETTES WHILE USING AN OXYGEN CONCENTRATOR. REPORTEDLY, THE INCIDENT WAS THE THIRD TIME THIS END USER SMOKED WHILE USING THE DEVICE, AND HAD PREVIOUSLY SIGNED A "SMOKER PATIENT RELEASE," BECAUSE IT WAS NOTED BY THE PROVIDER THAT HE WAS STILL SMOKING IN THE PRESENCE OF HIS OXYGEN THERAPY TREATMENT. THE END USER WAS BURNED AND WAS TAKEN TO THE HOSPITAL WHERE THE END USER EXPIRED. THERE WAS NO REPORT OF A DEVICE MALFUNCTION. THE DEVICE CONTAINS SEVERAL WARNINGS, IN FRENCH, 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

  Patient problems: Burn(s)

  MAUDE report 18336398 ↗

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