CLASS II ONGOING Device recall · Reported 30 Sep 2026 · FDA Enforcement Report
Volara System Volara, HC, NA recalled by Baxter Healthcare
Baxter Healthcare is recalling Volara System Volara, HC, NA A, distributed nationwide in the US. The recall was initiated on 3 Aug 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3257-2026
- FDA event ID
- 99681
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Aug 2026
- FDA classified
- 23 Sep 2026
- Reported
- 30 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 3 Aug 2026 | Recall initiated by company | |
| 23 Sep 2026 | Classified by FDA | +51 days |
| 30 Sep 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution in the states of Colorado and Florida.
Questions about this recall
Why was it 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.
Which lots are affected?
Lot Code: UDI: 00887761981690 Serial Numbers: W078SY3553 and Z309SY7853
Where was it sold?
US Nationwide distribution in the states of Colorado and Florida.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 6 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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