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Baxter Volara Respiratory Therapy Blue Ventilator Adapter Module
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MEDICAL DEVICE RECALLCRITICAL

Baxter Volara Respiratory Therapy Blue Ventilator Adapter Module

Baxter is correcting its Volara Respiratory Therapy Blue Ventilator Adapter Module (M07937) due to risks of oxygen desaturation or barotrauma in home care use.

What to do

If you use the Baxter Volara Respiratory Therapy system with the Blue Ventilator Adapter Module (Product Code M07937) at home, review the updated instructions for use provided by Baxter Healthcare Corporation immediately. Monitor for signs of oxygen desaturation and follow all new guidance to prevent lung tissue injury. Contact Baxter Healthcare Corporation or your healthcare provider with any questions.

Posted
Updated
Recall No.
Z-1637-2026
Agency
Firm
Baxter Healthcare Corporation
Recall ID
98458
Status
ONGOING

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.

How to identify it

UPC 00887761984622

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

Where it was sold

Distributed in US-FL.

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Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification