Hillrom VOLARA P.CIRCUIT 5KIT Recall Issued by Baxter
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Baxter Healthcare Corporation is recalling Hillrom VOLARA P.CIRCUIT 5KIT devices 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 8, 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
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.
Which Products Are Affected
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270. UDI: 10887761985015. Lot Numbers: All lot numbers distributed beginning on 4/28/2025. Distributed to US Nationwide and Canada.
What You Should Do
The recall is voluntary and firm initiated. No specific consumer action steps are provided in the recall notice.
Why This Matters
This Class I recall involves a device that may affect delivery of prescribed treatment due to leakage during therapy.
Source
FDA recall number Z-2549-2026, event ID 99119.
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 (1,000 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.