Hillrom VOLARA P.CIRCUIT 5KIT recall (Baxter Healthcare Corporation)
Medical deviceClass IOngoing
Summary: Baxter Healthcare Corporation is recalling Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device. Reason: There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
What is being recalled
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
Why
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
How serious is it
Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.
Where it was sold
Worldwide distribution - US Nationwide and the country of Canada.
How to tell if yours is affected
UDI: 10887761985015; Lot Numbers: All lot numbers distributed beginning on 4/28/2025
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2549-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | May 21, 2026 |
| Reported | July 8, 2026 |
| Company | Baxter Healthcare Corporation |
| Company location | Deerfield, IL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 0 |
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