Baxter Volara System
Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Baxter Healthcare Corporation recalled the VOLARA System, VOLARA, HC, NA A, model M08594A, because contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. The company began the recall on August 3, 2026, and the FDA added it to its Enforcement Report on September 23, 2026. Affected devices returned to the firm and testing confirmed the devices meet specifications.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number matches.
Volara, HC, NA a
- Model
- M08594A
Details
- Company began the recall
- Event ID
- 99681
- Recall No.
- Z-3257-2026
- Company
- Baxter Healthcare CorporationDeerfield, Illinois
- Hazard
- Contamination
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
