Recall Z-3257-2026 ยท NHJ Device, Positive Pressure Breathing, Intermittent
Baxter Healthcare Corporation
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
| Date | Sep 23, 2026 (initiated Aug 3, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| 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. |
| Quantity | 2 |
| Distribution | US Nationwide distribution in the states of Colorado and Florida. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200988 | Maximus System Hill-Rom Services Pte, Ltd., May 26, 2020 |