Recall Atlas

Vyaire Medical recalls

6 official recalls and safety alerts involving Vyaire Medical since 2022-02, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Vyaire Medical or the relevant agency.

  1. 2025-05-21
  2. US
    Drugs & medicalClass I

    Vyaire Medical recalls Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product…

    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.

    FDA · DeviceVyaire MedicalWorldwide distribution - US Nationwide and the countries of Germany, Poland,…Official notice →
  3. 2024-05-15
  4. US
    Drugs & medicalClass I

    Vyaire Medical, Inc. recalls Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX.…

    Potential of the nozzle separating during patient use.

    FDA · DeviceVyaire Medical, Inc.US nationwide distribution.Official notice →
  5. 2024-03-06
  6. US
    Drugs & medicalClass I

    Vyaire Medical recalls AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F

    Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may…

    FDA · DeviceVyaire MedicalWorldwide distribution. US nationwide, Brazil, Canada, Switzerland, France,…Official notice →
  7. 2023-12-13
  8. US
    Drugs & medicalClass II

    Vyaire Medical recalls vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)

    Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S.

    FDA · DeviceVyaire MedicalUS: FloridaOfficial notice →
  9. 2023-06-21
  10. US
    Drugs & medicalClass II

    Vyaire Medical recalls bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator

    Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application…

    FDA · DeviceVyaire MedicalUS Nationwide DistributionOfficial notice →
  11. 2022-02-23
  12. US
    Drugs & medicalClass I

    Vyaire Medical recalls bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e ventilator is…

    Potential cessation in ventilation can occur under specific conditions.

    FDA · DeviceVyaire MedicalWorldwide distribution - US Nationwide distribution in the states of AL, CA,…Official notice →