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# Baxter Volara System Recall is Class 1
- URL: https://www.fdaweb.com/baxter-volara-system-recall-is-class-1-2/
- Published: 2022-06-23T12:00:00.000Z
- Updated: 2026-09-14T17:49:52.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152138

FDA says Baxter Healthcare’s 4/26 recall of 268 units of its Volara system with an in-line ventilator adaptor is Class 1\. An agency [notice](https://www.fda.gov/medical-devices/medical-device-recalls/baxter-healthcare-corporation-recalls-volara-system-risk-respiratory-distress-ventilated-patients?ref=fdaweb.com) says the devices were distributed between 5/28/20 and 4/19/22\. The system is intended to help people clear mucus out of their airways, expand the lungs, and to treat or prevent a partially collapsed lung.

Baxter recalled the units because the in-line ventilator adaptor may prevent home-use patients from getting enough oxygen from their ventilators. FDA says the risk of serious injury or death is more significant in home-care settings if the caregivers are not trained properly, the device is not connected properly, or if the caregiver is not prepared to address any issues that may arise caused by using the device.

The notice says there has been one complaint and one injury, as well as two deaths, associated with using the device.