TemporaryFDAOngoing
Can cause harm that is usually temporary.
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
Check the device or its packaging for
Lot Code: UDI: 00887761981690 Serial Numbers: W078SY3553 and Z309SY7853
- Why
- 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.
- Distributed
- US Nationwide distribution in the states of Colorado and Florida.
- Company
- Baxter Healthcare Corporation
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-3257-2026 · retrieved 23 September 2026
Read the official notice