Vyaire Medical recalls

13 recalls in our records from 2017 to 2025: 13 FDA medical devices.

Recalls with full detail pages

• FDA · Medical devicesClass IMay 21, 2025

  Vyaire Medical medical device recall: Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit…

  Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including…

Earlier and other recalls

These link to the official agency notice.

• FDA · Medical devicesClass IMay 15, 2024

  Vyaire Medical, Inc. medical device recall: Vyaire Medical GmbH Official notice ↗

  Potential of the nozzle separating during patient use.

• FDA · Medical devicesClass IMar 6, 2024

  Vyaire Medical medical device recall: AirLife Adult Manual Resuscitator Official notice ↗

  Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause…

• FDA · Medical devicesClass IIDec 13, 2023

  Vyaire Medical medical device recall: vyaire Flexible Patient Circuit Official notice ↗

  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…

• FDA · Medical devicesClass IIJun 21, 2023

  Vyaire Medical medical device recall: bellavista 1000 Ventilator Official notice ↗

  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…

• FDA · Medical devicesClass IFeb 23, 2022

  Vyaire Medical medical device recall: bellavista 1000 ventilator Official notice ↗

  Potential cessation in ventilation can occur under specific conditions.

• FDA · Medical devicesClass IIMar 11, 2020

  Vyaire Medical medical device recall: bellavista 1000 ventilator Official notice ↗

  The G6 bellavista 1000 US ventilators may experience intermittent failures: Lack of acoustic high priority alarm, presence of a 'no alarm' condition, or presence of…

• FDA · Medical devicesClass IJul 3, 2019

  Vyaire Medical medical device recall: enFlow Disposable Cartridge Official notice ↗

  Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.

• FDA · Medical devicesClass IAug 29, 2018

  Vyaire Medical medical device recall: The Tri-Flo Subglottic Suction System Official notice ↗

  Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Subglottic Suction System. The distal soft tip of the catheter has been…

• FDA · Medical devicesClass IAug 15, 2018

  Vyaire Medical medical device recall: AirLife Resuscitation Device Official notice ↗

  An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use.

• FDA · Medical devicesClass IMay 16, 2018

  Vyaire Medical medical device recall: AirLife Resuscitation Official notice ↗

  The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a…

• FDA · Medical devicesClass IJan 31, 2018

  Vyaire Medical medical device recall: Infant AirLife single-limb Official notice ↗

  Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in…

• FDA · Medical devicesClass IISep 6, 2017

  Vyaire Medical medical device recall: AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER Official notice ↗

  Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23 Gage, 1" needle),…

Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.