- Recalling firm
- Baxter Healthcare Corporation
- 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.
- Affected products (lot / model / serial)
- UDI/DI number 00887761984622
- Units affected
- 19 units
- Distribution pattern
- Florida
- Firm location
- Deerfield, IL, United States
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1637-2026
- Recall initiated
- February 18, 2026
- FDA classification date
- April 1, 2026
- FDA report date
- April 8, 2026
- FDA event ID
- 98458
- Last updated on HTM Vibe
- July 24, 2026