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Vyaire Medical

61 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: recall (Z-1697-2025)Vyaire Medical2025-05-09
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: recall (Z-1698-2025)Vyaire Medical2025-05-09
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000, recall (Z-1057-2024)Vyaire Medical2024-02-25
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2 recall (Z-1058-2024)Vyaire Medical2024-02-25
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F recall (Z-1059-2024)Vyaire Medical2024-02-25
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8 recall (Z-1060-2024)Vyaire Medical2024-02-25
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8 recall (Z-1061-2024)Vyaire Medical2024-02-25
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expirat recall (Z-1062-2024)Vyaire Medical2024-02-25
AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 De recall (Z-1063-2024)Vyaire Medical2024-02-25
AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, RE recall (Z-1064-2024)Vyaire Medical2024-02-25
AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8 recall (Z-1065-2024)Vyaire Medical2024-02-25
vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A recall (Z-0488-2024)Vyaire Medical2023-12-05
vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A recall (Z-0489-2024)Vyaire Medical2023-12-05
bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator recall (Z-1966-2023)Vyaire Medical2023-06-15
bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator recall (Z-1967-2023)Vyaire Medical2023-06-15
bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100. recall (Z-0622-2022)Vyaire Medical2022-02-16
enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood sol recall (Z-1385-2019)Vyaire Medical2019-06-26
enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy wi recall (Z-1386-2019)Vyaire Medical2019-06-26
The Tri-Flo Subglottic Suction System recall (Z-2826-2018)Vyaire Medical2018-08-21
AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen recall (Z-2552-2018)Vyaire Medical2018-08-08
AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, recall (Z-2553-2018)Vyaire Medical2018-08-08
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag Product Usage: The AirLife R recall (Z-1547-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector Product Usage: recall (Z-1548-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, manometer Pro recall (Z-1549-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, filter Product Usage: The A recall (Z-1550-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer Product Usage: Th recall (Z-1551-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs Product Usage: T recall (Z-1552-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, filter Product Us recall (Z-1553-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-reli recall (Z-1554-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-reli recall (Z-1555-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief recall (Z-1556-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-reli recall (Z-1557-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-reli recall (Z-1558-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief recall (Z-1559-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief recall (Z-1560-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Infant, with mask, 40 inch oxygen reservoir tubing, pressure-relief recall (Z-1561-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Adult, with mask, 28inch large bore tubing Product Usage: The AirLi recall (Z-1562-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Pediatric, with mask, 28inch large bore tubing, pressure-relief val recall (Z-1563-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Infant, with mask, 28inch large bore tubing, pressure-relief valve recall (Z-1564-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve P recall (Z-1565-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve Prod recall (Z-1566-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Adult, with mask, 28inch large bore tubing, pressure-relief valve P recall (Z-1567-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, PEEP valve Product Usage: T recall (Z-1568-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve Pr recall (Z-1569-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEEP valve Produ recall (Z-1570-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, PEEP valve Produc recall (Z-1571-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-reli recall (Z-1572-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief recall (Z-1573-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, recall (Z-1574-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, manometer, pressure-rel recall (Z-1575-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-reli recall (Z-1576-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation device recall (Z-1577-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation device recall (Z-1578-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Replacement kit for outer shell, Broselow Product Usage: The AirLif recall (Z-1579-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief recall (Z-1580-2018)Vyaire Medical2018-05-10
AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve, PEE recall (Z-1581-2018)Vyaire Medical2018-05-10
Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing AirLife Humid recall (Z-0343-2018)Vyaire Medical2018-01-24
Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with AirLife Humidif recall (Z-0344-2018)Vyaire Medical2018-01-24
Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification Chamber, Mode recall (Z-0345-2018)Vyaire Medical2018-01-24
Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamb recall (Z-0346-2018)Vyaire Medical2018-01-24
AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUE recall (Z-3080-2017)Vyaire Medical2017-08-28

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Every clearance here is in the API, with alerts when new ones post.