FDAFDA recall Z-3257-2026 · Sep 30, 2026
Baxter Healthcare Corporation: Brand Name: VOLARA System Product Name: VOLARA recall
Recall found
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
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot Code: UDI: 00887761981690 Serial Numbers: W078SY3553 and Z309SY7853
- Quantity
- 2
- Distribution
- US Nationwide distribution in the states of Colorado and Florida.
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-03
Source: openFDA enforcement record Z-3257-2026 · search recall number Z-3257-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.