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
FDA Recall Z-3257-2026 · Posted 2026-09-23
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Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeNHJ
Date Initiated2026-08-03
Product Quantity2
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.
Firm Action
Affected consignees were notified by phone on August 3, 2026.
Customers were informed that as a precaution, Baxter would replace impacted VOLARA devices. A Baxter clinical trainer would contact the customers to schedule a home visit to exchange the device. Customers were asked to continue to use the VOLARA device as prescribed until it was exchanged.
As of August 13, 2026, all potentially affected devices have been returned to Baxter.
Root Cause
Device Design
Distribution Pattern
US Nationwide distribution in the states of Colorado and Florida.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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