Baxter Recalls Hillrom VOLARA System Circuit Kits
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Baxter Healthcare Corporation is recalling 16,187 units of the Hillrom VOLARA System P.CIRCUIT KIT AC due to reports of air and medication leakage from the nebulizer cup.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 7, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Baxter Healthcare Corporation initiated a recall of the Hillrom VOLARA System P.CIRCUIT KIT AC after 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, affecting delivery of the prescribed treatment. The issue is associated with improper locking of the nebulizer cup after adding medication.
Which Products Are Affected
The recall covers the Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473, used for Oscillation Lung Expansion Therapy and positive pressure breathing. A total of 16,187 units are affected. UDI: 00887761981492. All lot numbers distributed beginning on 4/28/2025. Distribution is nationwide in the US and Canada.
What You Should Do
Consumers and healthcare providers should be aware of the potential for leakage during setup and use of the device. Contact Baxter Healthcare Corporation for further information regarding the recall.
Why This Matters
This Class I recall involves a device where leakage may compromise oxygen levels and treatment delivery in patients using the Volara system.
Source
FDA recall number Z-2550-2026, event ID 99119. Baxter Healthcare Corporation, Deerfield, IL.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,306 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.