FDA DevicesClass I
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937....
Published: April 8, 2026Recall ID: Z-1637-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
Affected Products
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
Additional Source Details
| Field | Value |
|---|---|
| City | Deerfield |
| State | IL |
| Event id | 98458 |
| Address 1 | 1 Baxter Pkwy |
| Code info | UDI/DI number 00887761984622 |
| Postal code | 60015-4625 |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 19 units |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260218 |
| Center classification date | 20260401 |
Overview
- Recalling FirmBaxter Healthcare Corporation
- StatusOngoing
- Risk LevelClass I
- DistributionFlorida