Hillrom recalls Volara System circuit kits with potential air leaks causing oxygen drops. Affected units have model REF M08473 and were sold starting April 28, 2025. Stop using if leaks occur.
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.
Baxter Healthcare Corporation recalls Hillrom Volara System circuit kits that may leak air during therapy, risking low oxygen levels and ineffective medication delivery. This happens when the nebulizer cup isn't properly locked after adding medication.
The nebulizer cup can leak air when not securely locked after medication is added. This causes oxygen levels to drop and medication to not work properly during therapy, potentially leading to ineffective treatment.
Patients using the Volara System circuit kit for home respiratory therapy are affected. Those who have the model REF M08473 with lot numbers starting April 28, 2025 are most at risk.
Check for the model number REF M08473 on the circuit kit. The product was sold starting April 28, 2025, with all lot numbers from that date onward.
Look for air leaks around the nebulizer cup after adding medication. If leaks occur, stop using the circuit kit immediately.
The recall record does not mention a fix or remedy.
The recall record does not specify actions beyond checking for leaks. Contact Hillrom for further guidance.
The product was sold starting April 28, 2025.
We’ve drafted a message you can send Hillrom to request your refund or repair — edit it as you like.
Subject: Recall Z-2550-2026 — Hillrom Hillrom Hello, I own a Hillrom that is covered by recall Z-2550-2026 from Hillrom. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.