Baxter Recalls Hillrom Volara Patient Circuit
Baxter recalled a Hillrom Volara patient circuit after reports of air and medication leakage from the nebulizer cup during therapy.
Baxter International (BAX) recalled the Hillrom VOLARA System P.CIRCUIT 5KIT AC, a single-patient-use circuit for an oscillation lung expansion therapy positive-pressure breathing device, in a Class I recall. Baxter Healthcare Corporation initiated the recall for model M08474, which carried FDA recall number Z-2551-2026.
Reports indicated air and medication leakage from the nebulizer cup during therapy using Volara system patient circuits. The leakage could lead to an oxygen-level drop in the patient and ineffective nebulization, which could affect 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 agency listed the recall’s status as “Ongoing,” its basis as “Voluntary: Firm initiated,” and its distribution as “Worldwide distribution - US Nationwide and the country of Canada.”
Baxter reported first-quarter 2026 sales from continuing operations of about $2.7 billion, up 3% on a reported basis and down 1% organically. The Healthcare Systems & Technologies segment generated about $705 million in sales, with Care & Connectivity Solutions sales approximately flat.
The FDA recorded three additional Class I recalls dated July 8 for other Hillrom VOLARA patient-circuit configurations tied to the same leakage reports, stated treatment effects and locking issue. Those recalls covered models M08473, M08085 and M08270, remained ongoing, were firm-initiated and had the same U.S. and Canadian distribution.
A separate Class I recall reported in July 2024 covered Volara single-patient-use circuit kits because the handset plug could disconnect from the nebulizer port on the blue ventilator adapter. The plug was required for proper operation and ventilator gas flow; that recall also remained ongoing.