O2 Cannula 001366Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10889483570166), received between Jun 20, 2025 and Sep 10, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (3 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Loose or Intermittent Connection

  Patient problems: Insufficient Information

  MAUDE report 50724144 ↗
• MalfunctionSep 10, 2026Loose or Intermittent Connection

  Patient problems: Insufficient Information

  MAUDE report 50724141 ↗
• MalfunctionMar 24, 2026Material Twisted/Bent

  A FAILED INTUBATION ATTEMPT WAS REPORTED DUE TO A SEVERELY KINKED AND COILED OXYGEN TUBE WHICH LEAD TO INADEQUATE OXYGEN FLOW TO THE NEOPUFF RESUSCITATOR CAUSING THE PATIENT TO DESATURATE AS LOW AS 14%. VENTILATION WAS IMMEDIATELY SWITCHED TO A FLOW-INFLATING RESUSCITATOR; THE FLOW WAS SET TO 8 L/MIN, TO PROVIDE POSITIVE PRESSURE VENTILATION (PPV); ADEQUATE CHEST RISE WAS PROMPTLY ACHIEVED AND THE PATIENT'S OXYGEN SATURATION IMPROVED RAPIDLY. THE OXYGEN TUBING ON THE NEOPUFF RESUSCITATOR WAS REPLACED WITH A NEW TUBE AND THE PATIENT WAS SUCCESSFULLY INTUBATED ON THE THIRD ATTEMPT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24682722 ↗
• MalfunctionDec 18, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED, THE OXYGEN (O2) TUBING WAS CONNECTED TO THE WALL AND THERE WAS NO AIRFLOW, DUE TO PRESSURE THE OXYGEN TUBING POPPED OFF THE WALL. THE EVENT DID NOT REACH PATIENT/PERSON, NO HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23845995 ↗
• MalfunctionSep 23, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3004748541-2025-00066 FOR THE SECOND REPORT. IT WAS REPORTED, AFTER THE PATIENT CONNECTED THE OXYGEN NASAL CANNULA, IT WAS FOUND TO BE KINKED AFTER MOBILIZATION WHICH RESULTED IN THE OXYGEN NOT BEING PROPERLY ADMINISTERED. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 23128728 ↗
• MalfunctionSep 23, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3004748541-2025-00065 FOR THE FIRST REPORT. IT WAS REPORTED, AFTER THE PATIENT CONNECTED THE OXYGEN NASAL CANNULA, IT WAS FOUND TO BE KINKED AFTER MOBILIZATION WHICH RESULTED IN THE OXYGEN NOT BEING PROPERLY ADMINISTERED. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 23128726 ↗
• MalfunctionSep 10, 2025Disconnection; Defective Component

  AIRLIFE NASAL CANNULA REFERENCE NUMBER 001366 CAME DEFECTIVE. ONE SIDE OF CANNULA IS NOT CONNECTED TO THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23014877 ↗
• MalfunctionJun 20, 2025Material Integrity Problem; Material Integrity Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3004748541-2025-00011 FOR THE FIRST REPORT. REFER TO 3004748541-2025-00013 FOR THE THIRD REPORT. IT WAS REPORTED, THE TUBE KINKED WHICH RESULTED IN A NON-DELIVERY OF OXYGEN. THERE WAS NO REPORTED INJURY.

  Patient problems: Low Oxygen Saturation

  MAUDE report 22302696 ↗
• MalfunctionJun 20, 2025Material Integrity Problem; Material Integrity Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3004748541-2025-00011 FOR THE FIRST REPORT, REFER TO 3004748541-2025-00012 FOR THE SECOND REPORT . IT WAS REPORTED, THE TUBE KINKED WHICH RESULTED IN A NON-DELIVERY OF OXYGEN. THERE WAS NO REPORTED INJURY.

  Patient problems: Low Oxygen Saturation

  MAUDE report 22302685 ↗
• MalfunctionJun 20, 2025Material Twisted/Bent; Material Twisted/Bent

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3004748541-2025-00012 FOR THE SECOND REPORT. REFER TO 3004748541-2025-00013 FOR THE THIRD REPORT. IT WAS REPORTED, THE TUBE KINKED WHICH RESULTED IN A NON-DELIVERY OF OXYGEN. THERE WAS NO REPORTED INJURY.

  Patient problems: Low Oxygen Saturation

  MAUDE report 22302681 ↗