Baxter Healthcare Corporation recalls Brand Name: VOLARA System Product Name: VOLARA
- Recalling company
- Baxter Healthcare Corporation
- 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
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 3, 2026
- Reported
- Sep 30, 2026
- Distribution
- US Nationwide distribution in the states of Colorado and Florida.
- Status
- Ongoing
- Quantity
- 2
- Lot / codes
- Lot Code: UDI: 00887761981690 Serial Numbers: W078SY3553 and Z309SY7853
- Company location
- Deerfield, IL
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3257-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3257-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.