Recall
FDAHealthMay 21, 2026

Baxter Healthcare Corporation — Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing devi

⚠️ 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.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
May 21, 2026

Worldwide distribution - US Nationwide and the country of Canada.

What's affected?

Product
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
Lot code
All

Additional details

UDI: 10887761985015; Lot Numbers: All lot numbers distributed beginning on 4/28/2025

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: 0.

View original FDA notice →

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