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Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device

Class I
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.
Distribution pattern
Worldwide distribution - US Nationwide and the country of Canada.
State
IL
Status
Ongoing
Recall number
Z-2549-2026
Recall initiated
May 21, 2026
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