Hillrom recalls Volara P.Circuit 5Kit (REF M08270) due to air and medication leaks causing oxygen drops. Patients may receive ineffective treatment if nebulizer cup isn't locked properly after adding medication.
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.
Hillrom is recalling Volara P.Circuit 5Kit (REF M08270) because improper locking of the nebulizer cup can cause air and medication leaks during therapy. This may lead to low oxygen levels and ineffective treatment for patients using the device.
The nebulizer cup can leak air and medication if not locked correctly after adding medication. This leakage may cause oxygen levels to drop in patients and reduce the effectiveness of their treatment.
Patients using the Hillrom Volara P.Circuit 5Kit (REF M08270) for home oxygen therapy are affected. Those who add medication to the nebulizer cup without ensuring it's properly locked are at higher risk.
Check for the model number REF M08270 on the Volara P.Circuit 5Kit packaging. The product was sold starting April 28, 2025, with all lot numbers from that date.
Ensure the nebulizer cup is properly locked after adding medication to prevent leaks.
Yes, if you have the Hillrom Volara P.Circuit 5Kit (REF M08270) with model number REF M08270, it is affected.
The device has a model number REF M08270 and was sold starting April 28, 2025. Check if the nebulizer cup locks properly after adding medication.
Ensure the nebulizer cup is properly locked after adding medication to prevent leaks. The recall does not require immediate replacement or return.
We’ve drafted a message you can send Hillrom to request your refund or repair — edit it as you like.
Subject: Recall Z-2549-2026 — Hillrom Hillrom Hello, I own a Hillrom that is covered by recall Z-2549-2026 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.
