Official recall notice
FDA DeviceClass IINotable
Volara HC Recall (Sep 2026) – Baxter Healthcare
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
- Recall date
- 2026-09-30
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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.
Product description
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.
Affected products
Lot Code: UDI: 00887761981690 Serial Numbers: W078SY3553 and Z309SY7853