Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product
Summary
The FDA issued a Class II for Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: by Baxter Healthcare Corporation. Reason: Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to f.
Details
Source
Device Recall
External ID
Z-3257-2026
Action Date
2026-09-30
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: Lot Code: UDI: 00887761981690 Serial Numbers: W078SY3553 and Z309SY7853
Quantity Affected: 2
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.
Distribution
US Nationwide distribution in the states of Colorado and Florida.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-03
Company
Deerfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 196 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Baxter Healthcare Corporation has 335 FDA actions in our database, including 311 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Baxter Healthcare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 335 FDA actions in our database, including 311 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3257-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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