Recall Record: Class I Recall: Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient… by Baxter Healthcare Corporation

Key facts

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Baxter Healthcare Corporation. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Baxter Healthcare Corporation should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Baxter Healthcare Corporation directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

What this classification means

A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class I, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

Baxter Healthcare Corporation’s FDA history

Argus HQ has recorded 208 total FDA actions tied to Baxter Healthcare Corporation: 0 warning letters, 208 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Why was Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use recalled?

FDA's recall record states the reason as: 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.

Who should I contact about this recall?

Contact Baxter Healthcare Corporation directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.

Has Baxter Healthcare Corporation had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 208 total FDA actions tied to Baxter Healthcare Corporation, including 208 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number Z-2551-2026.

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