Airlife™ Sterile Water for Inhalation, USP, 500 ml 002620 (UDI 10889483571477)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889483571477), received between Nov 19, 2025 and Nov 19, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Crack” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2025Crack; Crack

  THE USER FACILITY MED SUN REPORT (B)(4) REPORTED: PATIENT WAS HAVING DIFFICULTY BREATHING WITH RETRACTIONS. WHEN EQUIPMENT WAS CHECKED, THE AIRLIFE BUBBLE HUMIDIFICATION SYSTEM WAS LEAKING OXYGEN FROM THE FRONT. AFTER VERIFICATION FROM A SECOND EMPLOYEE, THE DEVICE WAS EXCHANGED WITH A NEW AIRLIFE SYSTEM. THE RT [RESPIRATORY THERAPIST] AND RN [REGISTERED NURSE] CALLED THE MEDICAL TEAM TO THE BEDSIDE AND WHILE THEY WERE THERE, RT NOTICED THE CRACK IN THE HUMIFICATION SYSTEM. THE PATIENT WAS ESSENTIALLY NOT GETTING ANY OXYGEN. HE REPLACED THE BOTTLE, AND THE BABY RECOVERED OVER TIME. HE COULDN'T SAY WHETHER IT WAS CRACKED WHEN THEY OPENED IT OR THE NURSE SOMEHOW CRACKED IT DURING SET UP. IT WAS ADDITIONALLY REPORTED: THE PATIENT HAD BEEN EXTUBATED [PRIOR TO THE EVENT] AFTER AN HOUR THE NURSE CALLED BECAUSE THE PATIENT WAS RETRACTING AND HAD AN INCREASED WORK OF BREATHING (WOB); THE BOTTLE ITSELF WAS FOUND TO BE CRACKED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23600764 ↗