- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
- Affected products (lot / model / serial)
- UDI: 00887761985018, Lot Numbers: All lot numbers distributed beginning on 4/28/2025
- Units affected
- 10540 units
- Distribution pattern
- Worldwide distribution - US Nationwide and the country of Canada.
- Firm location
- Deerfield, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2548-2026
- Recall initiated
- May 21, 2026
- FDA classification date
- July 1, 2026
- FDA report date
- July 8, 2026
- FDA event ID
- 99119
- Last updated on HTM Vibe
- July 23, 2026