AirLife™ AH165 (UDI 10190752145139)Recalls & reported problems
Airlife · AirLife™ Infant Heated Wire Circuit dual-limb, dual-heat, high-flow circuit (>4 L/min) · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190752145139), received between Mar 25, 2025 and Mar 25, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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 16, 2026.
Reports received per month
Recalls naming this device
- Apr 10, 2025Open, Classified
Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.
Z-1697-2025 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
DURING THESE PAST MONTHS, WHEN THE CIRCUIT HEATS UP TO 31C THE OXYGEN TUBE EXPANDS, AND IT FREQUENTLY JUST SLIPS APART BETWEEN THE HARD PLASTIC ADAPTOR ON THE CIRCUIT AND THE SHORT PIECE OF OXYGEN TUBING LEAVING THE PATIENT UNVENTILATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21693991 ↗
Other HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER devices
- VOCSN V*Home, EnglishVentec Life Systems, Inc. · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer4 deaths318 reports
- F&P Evaqua 2 RT380Fisher & Paykel Healthcare Limited · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer305 reports
- F&P Evaqua 2 RT265Fisher & Paykel Healthcare Limited · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer114 reports
- F&P Evaqua 2 RT266Fisher & Paykel Healthcare Limited · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer93 reports
- HUDSON RCI IPN046880Teleflex Incorporated · HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER1 recall0 reports
- HUDSON RCI IPN046879Teleflex Incorporated · HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER1 recall0 reports
- AirLife™ AH165Airlife · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer1 recall0 reports
- Fisher & Paykel Healthcare RT225Fisher & Paykel Healthcare Limited · Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer30 reports
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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page