Recall
FDAHealthFebruary 18, 2026

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

⚠️ 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.

Is this relevant to me?

Geography
Unknown
Source agency
FDA
Category
Health
Published
February 18, 2026

Florida

What's affected?

Product
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
Lot code
UDI/DI number 00887761984622

Additional details

UDI/DI number 00887761984622

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: 19 units.

View original FDA notice →

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