FDA Device Intelligence
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Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

FDA product code BZE · Class 2 · Anesthesiology

393
Registered devices
3,525
Adverse events
7
Recalls
46
510(k) clearances

Devices with this code

AirLife™ — AIRLIFEFilter — WESTMED, INC.VentStar Helix heated (N) Plus — Drägerwerk AG & Co. KGaANeonatal Single Heated Wire Breathing System 1.25m with 1 x Water Trap — FLEXICARE MEDICAL LIMITEDAirLife — Carefusion CorporationHybernite RT — Plastiflex Group NVAirLife — Carefusion CorporationHUDSON RCI — TELEFLEX INCORPORATEDAirLife — Carefusion CorporationThermalite Heated CPAP Tube — EXCELERON MEDICAL, INC.AirLife — Carefusion CorporationAdult Smoothbore Single Limb H/W B/c Kit 1.6M (63") (Kit 1) — FLEXICARE MEDICAL LIMITEDAirLife™ — AIRLIFEFlexicare — FLEXICARE MEDICAL LIMITEDHybernite RT — Plastiflex Group NVVOCSN Patient Breathing Package — Ventec Life Systems, Inc.AirLife — Carefusion CorporationAirLife™ — AIRLIFEVOCSN Patient Breathing Package — Ventec Life Systems, Inc.AirLife™ — AIRLIFEAirLife™ — AIRLIFEN/A — Intersurgical IncorporatedHUDSON RCI — MEDLINE INDUSTRIES, INC.AirLife™ — AIRLIFE

Recent recalls

DateFirmReason
2025-04-10Vyaire MedicalAdapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, in
2025-04-10Vyaire MedicalAdapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, in
2019-05-10Teleflex MedicalReported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.
2014-07-31Carefusion 2200 IncThe CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. The changes to the gas
2012-05-29Carefusion 2200 IncThe Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the
2012-05-29Carefusion 2200 IncThe Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the
2012-05-29Carefusion 2200 IncThe Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.