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Vyaire Medical FDA Recalls
16 recalls on file across devices, 12 of them Class I and 11 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/Class IApr 10, 2025Adapters may disconnect during setup or while in use, potent |
| Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/Class IApr 10, 2025Adapters may disconnect during setup or while in use, potent |
| AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017Class IJan 10, 2024Risk of hypoventilation caused by duckbill and ring broken/d |
| AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004FClass IJan 10, 2024Risk of hypoventilation caused by duckbill and ring broken/d |
| AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2Class IJan 10, 2024Risk of hypoventilation caused by duckbill and ring broken/d |
| AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005FClass IJan 10, 2024Risk of hypoventilation caused by duckbill and ring broken/d |
| AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004Class IJan 10, 2024Risk of hypoventilation caused by duckbill and ring broken/d |
| AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005Class IJan 10, 2024Risk of hypoventilation caused by duckbill and ring broken/d |
| AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,Class IJan 10, 2024Risk of hypoventilation caused by duckbill and ring broken/d |
| AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2Class IJan 10, 2024Risk of hypoventilation caused by duckbill and ring broken/d |
| AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001Class IJan 10, 2024Risk of hypoventilation caused by duckbill and ring broken/d |
| vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory VenClass IIOct 27, 2023Two patient circuits, 29028-003 and 29028-004, for the 3100 |
| vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory VenClass IIOct 27, 2023Two patient circuits, 29028-003 and 29028-004, for the 3100 |
| bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use VentilatorClass IIMay 5, 2023Vyaire Medical identified two patient safety risks during th |
| bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use VentilatorClass IIMay 5, 2023Vyaire Medical identified two patient safety risks during th |
| bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/10Class IDec 20, 2021Potential cessation in ventilation can occur under specific |