⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Baxter Healthcare Corporation: Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA

Medical DevicesSource: FDA (device) · Date: 2026-09-30

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Baxter Healthcare Corporation
Product
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
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of Colorado and Florida.
Recall initiated
2026-08-03
Code info
Lot Code: UDI: 00887761981690 Serial Numbers: W078SY3553 and Z309SY7853
Product quantity
2
Voluntary mandated
Voluntary: Firm initiated
City
Deerfield
State
IL
Country
United States
Event id
99681
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