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Recall Observatory FDA recall evidence

Device product

Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device

Z-2551-2026

May 21, 2026

Class I

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 99119
Status
Ongoing
Classification
Class I
Quantity
13881 units
Official record key
device-enforcement:Z-2551-2026

Official wording

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.

Code information: UDI: 10887761981499; Lot Numbers: All lot numbers distributed beginning on 4/28/2025

Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.