Vyaire Medical

FDA Regulatory Profile

Summary

Total Recalls
63 (57 Class I)
510(k) Clearances
11
Inspections
13
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1697-2025Class IBrand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 April 10, 2025
Z-1698-2025Class IBrand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 April 10, 2025
Z-1730-2024Class IVyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sampleApril 8, 2024
Z-1064-2024Class IAirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017January 10, 2024
Z-1058-2024Class IAirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001January 10, 2024
Z-1060-2024Class IAirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2January 10, 2024
Z-1059-2024Class IAirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004FJanuary 10, 2024
Z-1057-2024Class IAirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,January 10, 2024
Z-1063-2024Class IAirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REJanuary 10, 2024
Z-1065-2024Class IAirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004January 10, 2024
Z-1062-2024Class IAirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory FilterJanuary 10, 2024
Z-1061-2024Class IAirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005January 10, 2024
Z-0488-2024Class IIvyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High FrequOctober 27, 2023
Z-0489-2024Class IIvyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High FrequOctober 27, 2023
Z-1967-2023Class IIbellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use VentilatorMay 5, 2023
Z-1966-2023Class IIbellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use VentilatorMay 5, 2023
Z-0622-2022Class Ibellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. ThDecember 20, 2021
Z-1439-2020Class IIbellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled November 25, 2019
Z-1386-2019Class IenFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid aMarch 13, 2019
Z-1385-2019Class IenFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.March 13, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K230915AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen MaskNovember 12, 2024
K231380AirLife DuoTherm™ Humidification SystemAugust 10, 2023
K201082LTV2 Series VentilatorsNovember 10, 2021
K211294Multi-Link X2 ECG Cable and Leadwire SystemAugust 16, 2021
K200510Multi-LinkTM X2 ECG Adapter and LeadwiresOctober 9, 2020
K191273Multi-Link X2 ECG and SpO2 AdapterSeptember 13, 2019
K183567Vyntus/SentrySuite Product LineAugust 23, 2019
K190853Vyntus BODYAugust 16, 2019
K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFTNovember 30, 2018
K171678Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, CApril 30, 2018
K170378AirLife Adult Heated Wire BiPAP/NIV CircuitSeptember 14, 2017