Drug & Device Safety Atlas

FDA recall record · openFDA

Vyaire Medical

15 FDA recalls on record (2023–2025) — 15 device. 15 still ongoing.

11
Class I (most serious)
4
Class II
0
Class III
15
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of spe 9
Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved 2
Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result 2
Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under 2

Recalls

Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/ Class I 2025-04-10 Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/ Class I 2025-04-10 AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F Class I 2024-01-10 AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017 Class I 2024-01-10 AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8005 Class I 2024-01-10 AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2 Class I 2024-01-10 AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F Class I 2024-01-10 AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2 Class I 2024-01-10 AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001 Class I 2024-01-10 AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000, Class I 2024-01-10 AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004 Class I 2024-01-10 vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ven Class II 2023-10-27 vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ven Class II 2023-10-27 bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator Class II 2023-05-05 bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator Class II 2023-05-05

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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