Medical Device Recall: Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
Baxter Healthcare Corporation · May 21, 2026
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
Worldwide distribution - US Nationwide and the country of Canada.
States Affected
NATIONWIDE
Quantity Affected
0
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2549-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.