AirLife SO-1968-0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607411918025), received between May 25, 2023 and Dec 24, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3004748541-2025-00159 FOR THE SECOND REPORT. IT WAS REPORTED THAT ON (B)(6) 2025, THE NOZZLE THAT ATTACHED TO THE TANK DETACHED FROM THE TUBING (IT DID NOT STAY IN PLACE). IT WAS ADDITIONALLY REPORTED THAT THIS IS THE SECOND TIME IN A SHORT PERIOD OF TIME THIS HAS HAPPENED; HOWEVER, IT WAS NOTED, THERE WERE NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23891169 ↗
• MalfunctionDec 24, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3004748541-2025-00158 FOR THE FIRST REPORT. IT WAS REPORTED, THE NOZZLE THAT ATTACHED TO THE TANK DETACHED FROM THE TUBING (IT DID NOT STAY IN PLACE). IT WAS ADDITIONALLY NOTED; THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23891166 ↗
• InjuryMay 25, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  VERY CLEAR CUTS LOCATED 4 DIFFERENT PLACES ON THE O2 TUBING W/CONNECTOR  THE PATIENT DESATURATED WHILE PLUGGED INTO HIS TANK WHILE THE SATURATION WAS GOOD WHEN PLUGGED INTO THE LAPTOP. THE TUBING WAS DISCOVERED WITH VERY CLEAR CUTS OF 1 TO 2 CM LOCATED IN 4 DIFFERENT PLACES OVER THE LAST 2 METERS AT ONE END.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 17004029 ↗