Baxter Healthcare Corporation recalls Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory…

Recall date

February 18, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1637-2026

FDA classification

Class I

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

Florida

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.