Baxter Recalls Hillrom VOLARA Circuit Kit
Baxter recalled a Hillrom VOLARA patient circuit kit after reports of air and medication leakage from the nebulizer cup during therapy.
Baxter International (BAX) recalled the Hillrom VOLARA System P.CIRCUIT KIT AC, a single-patient-use circuit for an oscillation lung expansion therapy positive pressure breathing device, in an FDA Class I recall. Baxter Healthcare Corporation was the recalling firm for Model/Catalog Number REF M08473, identified under recall number Z-2550-2026.
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 issue was associated with improper locking of the nebulizer cup after medication was added during user setup. The FDA listed the status as “Ongoing,” the basis as “Voluntary: Firm initiated,” and the 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. Its Healthcare Systems & Technologies segment recorded about $705 million in sales, flat on a reported basis and down 2% organically. The company reiterated its full-year outlook for reported sales growth of flat to 1% and adjusted earnings from continuing operations of $1.85 to $2.05 per diluted share.
The FDA also recorded three other ongoing Class I recalls reported July 8 for VOLARA single-patient-use circuit models M08474, M08085 and M08270, each citing the same leakage issue, voluntary firm initiation and distribution across the United States and Canada. A separate ongoing Class I recall reported in July 2024 covered VOLARA circuit kits over the potential for a handset plug to disconnect from the nebulizer port on the blue ventilator adapter.