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.
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