Class II
Medical Device Recall: Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, HOMECARE, NORTH AMERICA Component: No
Baxter Healthcare Corporation · August 3, 2026
Reason for Recall
Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications.
Distribution
US Nationwide distribution in the states of Colorado and Florida.
States Affected
NATIONWIDE
Quantity Affected
2
Source: FDA (openFDA Device Enforcement)
Recall number: Z-3257-2026
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.