AirLife™ SFT2601Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10190752117730), received between Nov 19, 2025 and Jan 2, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2026Incomplete or Inadequate Connection

  MED SUN MW REPORT MW (B)(4) REPORTED, "INFANT WAS SLEEPING IN RADIANT WARMER AND HAVING PHOTOGRAPHS TAKEN WHEN THIS RN SAW THAT INFANT BEGAN DESATURATING AND SATTING IN THE 70S. DUE TO A HISTORY OF THESE DEVICES FAILING, THIS RN IMMEDIATELY LOOKED TO SEE IF THE NASAL CANNULA HAD FALLEN OFF OF THE HUMIDIFIER AND IT HAD. NASAL CANNULA WAS RE-SECURED TO THE HUMIDIFIER. SATURATIONS IMPROVED IMMEDIATELY."

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 23952221 ↗
• InjuryNov 19, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  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 3004748541-2025-00124 FOR THE SECOND REPORT REFER TO 3004748541-2025-00125 FOR THE THIRD REPORT. MED SUN USER FACILITY MDR REPORT -(B)(4) REPORTED: INFANT WAS DESATURATING AND REGISTERED NURSE (RN) FOUND THAT NASAL CANNULA HAD BECOME DISCONNECTED FROM THE HUMIDIFIER. NO ONE WAS IN THE ROOM WITH THE INFANT; IT HAD APPARENTLY FALLEN OFF OF CONNECTOR. RN RECONNECTED THE NASAL CANNULA TO THE HUMIDIFIER. THERE WERE NO CRACKS IN THE NASAL CANNULA TUBING. NO HARM TO THE PATIENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23600913 ↗
• InjuryNov 19, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  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 3004748541-2025-00123 FOR THE FIRST REPORTREFER TO 3004748541-2025-00124 FOR THE SECOND REPORT MED SUN USER FACILITY MDR REPORT -3902560000-2025-8143 REPORTED: WENT TO BEDSIDE FOR MIDNIGHT CARE TIME FOR INFANT. TRACED LINES WITH PRECEPTOR AND FOUND NASAL CANNULA DISCONNECTED FROM HUMIDITY AND ON THE GROUND. CONNECTION CLEANED AND REATTACHED TO HUMIDIFIER. NO INFANT DESATURATION NOTED. I NOTIFIED NICU "[NEONATAL INTENSIVE CARE UNIT]" PROVIDER. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23600912 ↗
• InjuryNov 19, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  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 3004748541-2025-00123 FOR THE FIRST REPORT. REFER TO 3004748541-2025-00125 FOR THE THIRD REPORT . MED SUN USER FACILITY MDR REPORT 3902560000-2025-8143 REPORTED: PATIENT'S NASAL CANNULA BECAME DISCONNECTED FROM THE HUMIDIFICATION CONNECTOR, AND THE PATIENT DESATURATED. PATIENT REQUIRED OXYGEN THERAPY TO BRING O2 [OXYGEN] SATS UP. NO HARM TO THE PATIENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23600911 ↗