Official recall notice

FDA DeviceClass INotable

FDA Recall: Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxte

Recall date
2026-04-08
FDA class
Class I

Why it was recalled

Hazard

Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment. This correction is providing the home caregiver specific instructions for use.

Recommended action

What to do

19 units

Product description

Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment. This correction is providing the home caregiver specific instructions for use.

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