Reported Sep 30, 2026 · Ongoing · Updated Oct 6, 2026
Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product…
Baxter Healthcare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- Brand NameVOLARA
- System Product NameVOLARA, HC
- NA A Model/Catalog NumberM08594A
- Software VersionN/A
- Product DescriptionVOLARA, HOMECARE
- NORTH AMERICA ComponentNo
- Lot codes and dates
- Lot CodeUDI: 00887761981690
- Serial NumbersW078SY3553 and Z309SY7853
- Amount recalled
- 2
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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