Recall Z-3257-2026
Baxter Healthcare Corporation · initiated August 3, 2026
Product
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
Codes / lots: Lot Code: UDI: 00887761981690 Serial Numbers: W078SY3553 and Z309SY7853
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-3257-2026
- Initiated
- August 3, 2026
- Posted by FDA
- September 23, 2026
- Product code
- NHJ – Device, Positive Pressure Breathing, Intermittent
- Quantity
- 2
- Distribution
- US Nationwide distribution in the states of Colorado and Florida.
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL