Volara System recallZ-3257-2026 · Baxter Healthcare Corporation · initiated Aug 3, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Device Design
What the company is doing
Affected 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.
Recall details
- Recall number
- Z-3257-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 3, 2026
- Posted by the FDA
- Sep 23, 2026
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 2
- Product code
- NHJ
- FDA submissions
- K200988
- Distribution
- US Nationwide distribution in the states of Colorado and Florida.
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
Code information (models, lots, serial numbers)
Lot Code: UDI: 00887761981690 Serial Numbers: W078SY3553 and Z309SY7853
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Volara System M08594AHill-Rom Services Pte. Ltd. · DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT1 recall2 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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