SeriousFDAOngoing
Can cause serious harm or death.
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
Check the device or its packaging for
UDI: 00887761985018, Lot Numbers: All lot numbers distributed beginning on 4/28/2025
- 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.
- Distributed
- Worldwide distribution - US Nationwide and the country of Canada.
- Company
- Baxter Healthcare Corporation
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2548-2026 · retrieved 1 July 2026
Read the official notice