Baxter Healthcare Corporation recalls Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product
Baxter recalls VOLARA System (model M08594A) due to potential contamination affecting nebulizer flow rate accuracy. Affected units were tested and confirmed safe after return.
Lower-risk 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.
What happened, in plain English
Baxter is recalling its VOLARA System (model M08594A) because contamination in the release test equipment could lead to inaccurate nebulizer flow rates. This does not pose a safety risk to users but requires testing to ensure proper function. Read more at govinfonow.com/recall/1292664-baxter-volara-system-recall-contamination-risk-in-flow-rate-testing.
Source Summary by GovInfoNow · govinfonow.com/recall/1292664-baxter-volara-system-recall-contamination-risk-in-flow-rate-testing · Published October 6, 2026 · Updated October 6, 2026 · FDA enforcement record: FDA #Z-3257-2026
Cite this page
“Baxter VOLARA System Recall: Contamination Risk in Flow Rate Testing.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/1292664-baxter-volara-system-recall-contamination-risk-in-flow-rate-testing. Based on FDA recall #Z-3257-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3257-2026%22&limit=1).
Why it’s dangerous
Contamination in the release test equipment flow path might cause the nebulizer to deliver incorrect flow rates. This could affect the device's performance but does not pose a direct safety hazard to users.
Who’s affected
Users of the VOLARA System in North America with model M08594A are affected. Those who have used the device for home care are most at risk due to potential flow rate inaccuracies.
How to tell if you have this one
Check for model number M08594A on the VOLARA System. The device is sold in North America under Baxter Healthcare Corporation. Serial numbers W078SY3553 and Z309SY7853 are associated with this recall.
- Brand
Baxter- Category
Medical device
What to do — step by step
Check Device Model
Verify the model number is M08594A on the VOLARA System.
Contact Baxter
Reach out to Baxter Healthcare Corporation for testing confirmation if the device is affected.
Questions people ask
Is this recall dangerous?
No, the recall addresses potential flow rate inaccuracies but does not pose a safety risk. Affected devices were tested and confirmed safe after return.
How do I know if my VOLARA System is affected?
Check for model number M08594A. The device is sold in North America and has serial numbers W078SY3553 or Z309SY7853.
Do I need to stop using the device?
No, the recall does not require immediate discontinuation. Affected units were tested and confirmed safe after return.
Contact Baxter
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-3257-2026 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-3257-2026 from Baxter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3257-2026 (August 3, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3257-2026 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.