AirLife™ CK0010Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10190752158450), received between Sep 6, 2021 and Aug 3, 2025 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  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 8030673-2025-00029 FOR THE SECOND REPORT. IT WAS REPORTED AFTER THE RESPIRATORY THERAPIST (RT) ESTABLISHED THE UNIT ON THE PATIENT IN THE INTENSIVE CARE UNIT (ICU), THE NURSE NOTICED THE PATIENT'S OXYGEN (O2) SATURATION DROPPED. THE RT WAS CALLED AND THE DEVICE WAS REMOVED AS THE PATIENT WAS STRUGGLING TO BREATHE AND THEIR SATURATIONS WERE SO LOW THEY HAD TO BE INTUBATED. IT WAS ADDITIONALLY REPORTED, THE PATIENT EXPERIENCED AN UNSPECIFIED LIFE THREATENING INJURY; NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 22696534 ↗
• InjuryAug 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  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 8030673-2025-00028 FOR THE FIRST REPORT. . IT WAS REPORTED, AN UNSPECIFIED SERIOUS EVENT OCCURRED DURING USE ON A PATIENT; NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22693071 ↗
• InjuryAug 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  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 8030673-2024-01036 FOR THE SECOND REPORT. IT WAS REPORTED AFTER THE RESPIRATORY THERAPIST (RT) ESTABLISHED THE UNIT ON THE PATIENT IN THE INTENSIVE CARE UNIT (ICU), THE NURSE NOTICED THE PATIENT'S OXYGEN (O2) SATURATION DROPPED. THE RT WAS CALLED AND THE DEVICE WAS REMOVED AS THE PATIENT WAS STRUGGLING TO BREATHE AND THEIR SATURATIONS WERE SO LOW THEY HAD TO BE INTUBATED. IT WAS ADDITIONALLY REPORTED, THE PATIENT EXPERIENCED AN UNSPECIFIED LIFE THREATENING INJURY; NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 22693019 ↗
• InjuryNov 27, 2024Loose or Intermittent Connection; Insufficient Device Problem Information; Incomplete or Inadequate Connection; Loose or Intermittent Connection; Insufficient Device Problem Information; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT "THE CATHETER HAS GOTTEN LOOSE FROM THE VERSO ADAPTER. WHEN TRYING TO PUT IT BACK SHE NOTICE THAT THE TIP OF THE CATHETER HAS BROKEN LOOSE AND ARE STUCK INSIDE THE VERSO ADAPTER".

  Patient problems: Low Oxygen Saturation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20793132 ↗
• MalfunctionAug 13, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE VYAIRE MEDICAL THAT THE NEB KIT W ADAPTER STERILE WATER 1000ML IS ATTACHED TO OXYGEN FLOW AND PLACED ON A PATIENT, THE WATER WOULD LEAK OUT OF THE ENTRAINMENT PORT ALL OVER THE FLOOR.THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17538074 ↗
• MalfunctionNov 9, 2021Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED THAT THE NEB KIT W ADAPTER STERILE WATER 1000ML EXPERIENCED STERILE WATER SPITTING OUT FROM THE WATER AND ENTERING THE CORRUGATED TUBING THAT IS ATTACHED TO THE PATIENT. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12780829 ↗
• InjuryOct 12, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE NEB KIT W ADAPTER STERILE WATER 1000ML EXPERIENCED STOPS MISTING AFTER INITIAL SETUP. THE ISSUE OCCURRED DURING PATIENT-USE AND AS AN INTERVENTION THE DEVICE WAS REPLACED WHEN THE PREVIOUS ONE WAS NOT WORKING ANYMORE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12620069 ↗
• InjurySep 6, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE NEB KIT W ADAPTER STERILE WATER 1000ML EXPERIENCED FAILURE TO NEBULIZE AS A RESULT PATIENT'S TRACH DRIED OUT AND EXPERIENCED THICKER SECRETIONS. AS AN INTERVENTION, REPLACED VYAIRE SYSTEM WITH F&K SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12428687 ↗