FDAFDA · Food and drugs·Recall number Z-2551-2026
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
Published July 8, 2026 · Recall initiated: May 21, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- Worldwide distribution - US Nationwide and the country of Canada.
- Lot
- UDI: 10887761981499; Lot Numbers: All lot numbers distributed beginning on 4/28/2025
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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