Baxter Recalls Hillrom Volara Patient Circuits
Baxter International recalled the Hillrom Volara P.Circuit 5Kit due to reports of air and medication leakage from the nebulizer cup.
Baxter International (BAX) recalled the Hillrom VOLARA P.CIRCUIT 5KIT, a system single patient use circuit for an oscillation lung expansion therapy positive pressure breathing device, as a Class I recall.
The recall was initiated because of reports of air and medication leakage from the nebulizer cup during therapy. 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 FDA associated the issue with improper locking of the nebulizer cup after medication was added during user setup. The voluntary recall is ongoing and covers worldwide distribution, including the United States and Canada.
Baxter reported first-quarter 2026 sales from continuing operations of $2.7 billion. The company is currently expanding its Growth and Performance System as an enterprise operating system for continuous improvement, having launched more than 230 initiatives in the first quarter.
This action follows several other Class I recalls reported on July 8, 2026, for similar Volara system patient circuits, including models REF M08474, REF M08473, and REF M08085, for the same leakage issues,,. In July 2024, the company also initiated a Class I recall for Volara single patient use circuits due to the potential for the handset plug to disconnect from the nebulizer port.