O2 Cannula 001365Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10889483570159), received between Aug 27, 2025 and Jul 2, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2026Material Twisted/Bent

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3004748541-2026-00124 FOR THE FIRST REPORT. IT WAS REPORTED THAT THE NEW NASAL CANNULA WAS BENDING AT THE BASE (DUE TO THE TUBING BEING SOFTER), WHERE THE TUBE STARTS WHEN CONNECTED TO PORTABLE OXYGEN TANKS WHICH RESULTED IN THE RESIDENT NOT GETTING ADEQUATE OXYGEN (O2). THERE WAS NO REPORT OF A DELAY IN THERAPY, HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT. ADDITIONAL INFORMATION RECEIVED ON 2026JUN03 REPORTED, WHEN THE PATIENT'S OXYGEN LEVEL WAS NOTED TO BE DECREASING THE TUBING WAS IMMEDIATELY TAPED (TO STRENGTHEN IT). IT WAS REPORTED THAT NO MEDICAL INTERVENTION WAS REQUIRED AND THE PATIENT WAS NOTED TO BE FINE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 25699766 ↗
• MalfunctionJul 2, 2026Material Twisted/Bent

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3004748541-2026-00125 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE NEW NASAL CANNULA WAS BENDING AT THE BASE (DUE TO THE TUBING BEING SOFTER), WHERE THE TUBE STARTS WHEN CONNECTED TO PORTABLE OXYGEN TANKS WHICH RESULTED IN THE RESIDENT NOT GETTING ADEQUATE OXYGEN (O2). THERE WAS NO REPORT OF A DELAY IN THERAPY, HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT. ADDITIONAL INFORMATION RECEIVED ON 2026JUN03 REPORTED, WHEN THE PATIENT'S OXYGEN LEVEL WAS NOTED TO BE DECREASING THE TUBING WAS IMMEDIATELY TAPED (TO STRENGTHEN IT). IT WAS REPORTED THAT NO MEDICAL INTERVENTION WAS REQUIRED AND THE PATIENT WAS NOTED TO BE FINE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 25699765 ↗
• MalfunctionJul 2, 2026Material Twisted/Bent

  THE HEALTHCARE PROVIDER (HCP) NOTED THAT THE TUBING WAS KINKED RIGHT ABOVE THE NIPPLE WHERE IT FIT ONTO THE OXYGEN (O2) TANK AND AN UNSPECIFIED DESATURATION EVENT OCCURRED. THE HCP MANUALLY OPENED THE KINK AND HELD IT OPEN WITH THEIR FINGERS AND THE O2 SATURATION RATE OF THE PATIENT RETURNED TO EXPECTED LEVELS. MINIMAL HARM REPORTED. ADDITIONAL INFORMATION RECEIVED 16JUN2026 REPORTED, THE RESIDENT RECOVERED FAIRLY QUICKLY AFTER THE PROBLEM WAS ADDRESSED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 25699688 ↗
• MalfunctionFeb 18, 2026Device-Device Incompatibility

  IT WAS REPORTED, THE NASAL CANNULA DID NOT FIT THE PORTABLE OXYGEN (O2) DEVICE. THERE WAS NO REPORT OF A DELAY IN THERAPY, HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24385115 ↗
• MalfunctionDec 5, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED, THE END THAT CONNECTED TO THE OXYGEN UNHOOKED/DISCONNECTED FROM THE REST OF THE TUBING THAT WENT TO THE PATIENT DURING THE BRONCHOSCOPY PROCEDURE. AS A RESULT, THERE WAS A BRIEF DELAY, OF APPROXIMATELY FIVE MINUTES, WHICH WAS THE TIME REQUIRED TO SET UP A NEW OXYGEN THERAPY CIRCUIT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728076 ↗
• MalfunctionOct 16, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  THE OXYGEN TUBING DID NOT STAY IN PLACE DURING THE FOLLOWING PROCEDURES: GASTROSCOPY, COLONOSCOPY, FLEXIBLE SIGMOIDOSCOPY, BRONCHOSCOPY FOR THE VULNERABLE GERIATRIC PATIENT. THE NASAL CANNULA CAME OUT; THE CLAMP WAS VERY DIFFICULT TO ADJUST, AND THE CONNECTION WAS NOT TIGHT AND CAME APART EASILY. THIS RESULTED IN A DELAY IN TREATMENT/THERAPY AND RESULTED IN MINIMAL (UNSPECIFIED) HARM TO THE PATIENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23318688 ↗
• MalfunctionAug 27, 2025Patient Device Interaction Problem; Patient Device Interaction 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 3004748541-2025-00053 FOR THE FIRST REPORT REFER TO 3004748541-2025-00054 FOR THE SECOND REPORT. IT WAS REPORTED: THE NASAL CANNUAL WAS FLARED [AT THE] TIP AND DID NOT STAY IN THE PATIENTS' NARES. THEY WE WERE GETTING INACCURATE OXYGEN (O2) SATURATION LEVELS FOR THE SEDATED PATIENT, WHICH RESULTED IN [THE] PATIENT NOT GETTING THE REQUIRED AMOUNT OF OXYGEN... [THE] PATIENT REQUIRED ANOTHER MASK/DEVICE; THERE WAS NO REPORTED INJURY.

  Patient problems: Low Oxygen Saturation

  MAUDE report 22909222 ↗
• MalfunctionAug 27, 2025Patient Device Interaction Problem; Patient Device Interaction 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 FIRST OF THREE REPORTS. REFER TO 3004748541-2025-00054 FOR THE SECOND REPORT. REFER TO 3004748541-2025-00055 FOR THE THIRD REPORT. IT WAS REPORTED: THE NASAL CANNUAL WAS FLARED [AT THE] TIP AND DID NOT STAY IN THE PATIENTS' NARES. THEY WE WERE GETTING INACCURATE 0XYGEN (O2) SAURATION LEVELS FOR THE SEDATED PATIENT, WHICH RESULTED IN [THE] PATIENT NOT GETTING THE REQUIRED AMOUNT OF OXYGEN... [THE] PATIENT REQUIRED MORE 02 TO BE DELIVERED BY HOLDING THE NASAL CANNULA IN PLACE. THERE WAS NO RPEORTED INJURY.

  Patient problems: Low Oxygen Saturation

  MAUDE report 22908706 ↗
• MalfunctionAug 27, 2025Patient Device Interaction Problem; Patient Device Interaction 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 3004748541-2025-00053 FOR THE FIRST REPORT. REFER TO 3004748541-2025-00055 FOR THE THIRD REPORT. IT WAS REPORTED: THE NASAL CANNULA WAS FLARED AT THE TIP AND DID NOT STAY IN THE PATIENTS' NARES. THEY WE WERE GETTING INACCURATE OXYGEN (O2) SATURATION LEVELS FOR THE SEDATED PATIENT, WHICH RESULTED IN THE PATIENT NOT GETTING THE REQUIRED AMOUNT OF OXYGEN. THE PATIENT REQUIRED ANOTHER MASK/DEVICE; THERE WAS NO REPORTED INJURY.

  Patient problems: Low Oxygen Saturation

  MAUDE report 22907852 ↗