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
Published September 30, 2026 · Recall initiated: August 3, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- US Nationwide distribution in the states of Colorado and Florida.
- Lot
- Lot Code: UDI: 00887761981690 Serial Numbers: W078SY3553 and Z309SY7853
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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Questions about this recall
Was 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 recalled?
Yes. FDA published recall Z-3257-2026 on September 30, 2026. Reported 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.
What should I do if I have this product?
Voluntary: Firm initiated · Telephone
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