Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer
Anesthesiology · 21 CFR 868.5270
Recent MDR events
3,525 adverse event reports on file
- F&P Evaqua 2Jul 29, 2026MalfunctionFisher & Paykel Healthcare Ltd9611451-2026-02338
- F&P Evaqua 2Jul 28, 2026MalfunctionFisher & Paykel Healthcare Ltd9611451-2026-02305
- F&P Evaqua 2Jul 27, 2026MalfunctionFisher & Paykel Healthcare Ltd9611451-2026-02238
- F&P Evaqua 2Jul 27, 2026MalfunctionFisher & Paykel Healthcare Ltd9611451-2026-02249
- F&P Evaqua 2Jul 27, 2026MalfunctionFisher & Paykel Healthcare Ltd9611451-2026-02289
- HUDSON RCIJul 22, 2026MalfunctionMedline Industries, Lp1417592-2026-07579
- F&P EVAQUA 2Jul 21, 2026MalfunctionFisher & Paykel Healthcare Ltd9611451-2026-02275
- F&P EVAQUA 2Jul 16, 2026MalfunctionFisher & Paykel Healthcare Ltd9611451-2026-02176
- F&P EVAQUA 2Jul 16, 2026MalfunctionFisher & Paykel Healthcare Ltd9611451-2026-02195
- F&P EVAQUA 2Jul 15, 2026MalfunctionFisher & Paykel Healthcare Ltd9611451-2026-02090
Event type breakdown
Recalls
7 recall events for this product code
- Vyaire MedicalOpen, ClassifiedMay 9, 2025
Brand Name: AirLife
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 · View FDA record ↗ - Vyaire MedicalOpen, ClassifiedMay 9, 2025
Brand Name: AirLife
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-1698-2025 · View FDA record ↗ - Teleflex MedicalTerminatedJul 15, 2019
Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column:
Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.
Z-1912-2019 · View FDA record ↗ - Carefusion 2200 IncTerminatedSep 23, 2014
CareFusion AirLife Heated Infant Breathing Circuit
The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. The changes to the gas pathway may potentially impact the safety of the device and quality of the gas condensates to the patient.
Z-2689-2014 · View FDA record ↗ - Carefusion 2200 IncTerminatedJun 29, 2012
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda
The 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 tidal volume delivered to the ventilated patient.
Z-1899-2012 · View FDA record ↗ - Carefusion 2200 IncTerminatedJun 29, 2012
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba L
The 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 tidal volume delivered to the ventilated patient.
Z-1900-2012 · View FDA record ↗ - Carefusion 2200 IncTerminatedJun 29, 2012
AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx device for single patient use; 30 connectors per box; CareFusion, 22745 Savi
The 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 tidal volume delivered to the ventilated patient.
Z-1901-2012 · View FDA record ↗
Registered firms
101 firms currently registered for this product code
Draegerwerk Ag & Co. Kgaa
LUEBECK Schleswig-Holstein, DE
Flexicare Medical Ltd.
RHONDDA CYNON TAFF Wales, GB
Productos Urologos De Mexico S.a. De C.v.
MEXICALI Baja California, MX
Teleflex Medical De Tecate, S. De R.l De C.v.
TECATE Baja California, MX
Uab Intersurgical
Visaginas Salcininkai, LT
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
Guang Dong Eda Technology Co., Ltd.
Dongguan City Guangdong, CN
Globalmed, Inc.
TRENTON Ontario, CA
Plastiflex Healthcare Division Of Plastiflex Group Nv
Paal Beringen Limburg, BE
Wilamed Gmbh
Kammerstein Bavaria, DE
Ventec Life Systems, Inc.
Woodinville, WA, US
Ceva Logistics Netherlands Bv (venray)
Oostrum Limburgh, NL
Teleflex Medical Llc
Morrisville, NC, US
Medline Industries, Lp - Northfield
Northfield, IL, US
Hamilton Medical Ag
BONADUZ Graubunden, CH
Sunset Healthcare Solutions Warehouse
Phoenix, AZ, US
510(k) clearances
46 clearances for this product code
- Vincent Healthcare Products LimitedJun 18, 2026
K252066 · inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidification Chamber (VHC10); inspired Auto-feed Humidification Chamber (VHC20)
- Medline Industries, LPMar 25, 2026
K253322 · Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT / Dri-Tech with 78 Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60 Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44 Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)
- Guangdong Eda Technology Co., Ltd.Jul 25, 2025
K243244 · Heated Breathing Tube
- Exceleron MedicalAug 2, 2024
K241268 · Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
- Medline Industries, LPJun 4, 2024
K234032 · Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line
- Draegerwerk AG & CO KgaaJun 14, 2023
K222822 · VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)
- Sunset Healthcare Solutions, Inc.Jan 29, 2021
K201418 · Sunset Heated CPAP Tube
- Teleflexmedical, Inc.Aug 2, 2018
K173280 · Neonatal ConchaSmart Breathing Circuits