FDA-Device2026-09-30Class IIPROCESSING DEFECT
Baxter VOLARA Homecare nebulizer system recalled for potential flow rate inaccuracy
What this means
During manufacturing quality testing, contamination in Baxter's test equipment may have affected the accuracy of nebulizer flow rate measurements on two VOLARA Homecare devices. The company has retrieved the affected units and retested them; both met specifications.
- Check if you have a VOLARA Homecare system with serial number W078SY3553 or Z309SY7853
- Contact Baxter Healthcare if you have one of these units
- Do not discard the device; return it to Baxter for verification
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of Colorado and Florida.
Affected count
2
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3257-2026More Baxter recalls
- FDA-Device2026-09-30Baxter Healthcare PRO+ 36" MRS SURFACE mattress recalled for incorrect UDI labeling
- FDA-Device2026-09-30Baxter PRO+ MRS SURFACE FOR VERSACARE mattress recalled for labeling error affecting bed frame compatibility
- FDA-Device2026-09-30Baxter PRO+ 40" MRS SURFACE mattress recalled for labeling error risk of incompatible bed frame use
- FDA-Drug2026-09-16Baxter Dextrose Injection 70% recalled for stainless steel particles
- FDA-Drug2026-09-09Baxter 0.9% Sodium Chloride Injection recalled for fiberglass contamination
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