AirLife™ 557071500Recalls & reported problems

AirLife Finland Oy · AirLife™ HMEF 1000/S With Flexible Tube, Disposable · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10889483586655), received between Jul 10, 2025 and Jul 10, 2025 — classified as 3 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Loose or Intermittent Connection3

Patient problems

No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 10, 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 3010838917-2025-00005 FOR THE FIRST REPORT. REFER TO 3010838917-2025-00006 FOR THE SECOND REPORT. IT WAS REPORTED, AFTER THE HUMIDITY MOISTURE EXCHANGE (HME) FLEX TUBE WAS SOILED IT DISCONNECTED FROM THE ENDOTRACHEAL TUBE (ETT) AND/OR TRACH, WHILE CONNECTED TO THE IN-LINE BALLARD SUCTION CATHETER. IT WAS ADDITIONALLY REPORTED, THE NURSE AND/OR RESPIRATORY THERAPIST (RT) RESPONDED PROMPTLY; HOWEVER THEIR ACTIONS WERE NOT SPECIFIED; THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22474757 ↗
MalfunctionJul 10, 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 3010838917-2025-00006 FOR THE SECOND REPORT. REFER TO 3010838917-2025-00007 FOR THE THIRD REPORT. IT WAS REPORTED, AFTER THE HUMIDITY MOISTURE EXCHANGE (HME) FLEX TUBE WAS SOILED IT DISCONNECTED FROM THE ENDOTRACHEAL TUBE (ETT) AND/OR TRACH, WHILE CONNECTED TO THE IN-LINE BALLARD SUCTION CATHETER. IT WAS ADDITIONALLY REPORTED, THE NURSE AND/OR RESPIRATORY THERAPIST (RT) RESPONDED PROMPTLY; HOWEVER, THEIR ACTIONS WERE NOT SPECIFIED; THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22474739 ↗
MalfunctionJul 10, 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 3010838917-2025-00005 FOR THE FIRST REPORT. REFER TO 3010838917-2025-00007 FOR THE THIRD REPORT. IT WAS REPORTED, AFTER THE HUMIDITY MOISTURE EXCHANGE (HME) FLEX TUBE WAS SOILED IT DISCONNECTED FROM THE ENDOTRACHEAL TUBE (ETT) AND/OR TRACH, WHILE CONNECTED TO THE IN-LINE BALLARD SUCTION CATHETER. IT WAS ADDITIONALLY REPORTED, THE NURSE AND/OR RESPIRATORY THERAPIST (RT) RESPONDED PROMPTLY; HOWEVER, THEIR ACTIONS WERE NOT SPECIFIED; THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22474723 ↗

Device details

UDI-DI	`10889483586655`
Brand	AirLife™
Model	557071500
Company	AirLife Finland Oy
Product code	CAH · Filter, Bacterial, Breathing-Circuit
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 20, 2026

Device type (GMDN): Heat/moisture exchanger/microbial medical gas filter

A device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use device.

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All Filter, Bacterial, Breathing-Circuit devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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