VOLARA System Product Name recall
Baxter Healthcare Corporation recalled VOLARA System Product Name on September 30, 2026 because of contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. It was sold nationwide.
Why it was recalled
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's recalled
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
Quantity: 2
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Baxter Healthcare Corporation, Deerfield, IL
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
US Nationwide distribution in the states of Colorado and Florida. - Status
- Ongoing
- Recall number
- Z-3257-2026
- Source
- U.S. Food and Drug Administration
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