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U.S. Department of Health and Human Services

Class 2 Device Recall VOLARA System

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 Class 2 Device Recall VOLARA Systemsee related information
Date Initiated by FirmAugust 03, 2026
Date PostedSeptember 23, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3257-2026
Recall Event ID 99681
510(K)NumberK200988 
Product Classification Device, positive pressure breathing, intermittent - Product Code NHJ
ProductBrand 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
Code Information Lot Code: UDI: 00887761981690 Serial Numbers: W078SY3553 and Z309SY7853
FEI Number 1417572
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
1-847-9484770
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionAffected consignees were notified by phone on August 3, 2026. Customers were informed that as a precaution, Baxter would replace impacted VOLARA devices. A Baxter clinical trainer would contact the customers to schedule a home visit to exchange the device. Customers were asked to continue to use the VOLARA device as prescribed until it was exchanged. As of August 13, 2026, all potentially affected devices have been returned to Baxter.
Quantity in Commerce2
DistributionUS Nationwide distribution in the states of Colorado and Florida.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NHJ
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