Hillrom recalls VOLARA System P.CIRCUIT 5KIT AC (model REF M08474) due to oxygen leakage during therapy. This may cause low oxygen levels and ineffective treatment. Affected units were distributed starting April 28, 2025.
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 the VOLARA System P.CIRCUIT 5KIT AC (model REF M08474) because improper locking of the nebulizer cup can cause air and medication leakage 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 properly locked after adding medication. This leakage may cause oxygen levels to drop and reduce the effectiveness of the treatment, potentially affecting patient care.
Patients using the Hillrom VOLARA System P.CIRCUIT 5KIT AC for lung expansion therapy are affected. Those who have the model REF M08474 with distribution starting April 28, 2025 are most at risk.
Check for the model number REF M08474 on the device. Units were distributed starting April 28, 2025, with a unique device identifier (UDI) starting with 10887761981499.
Ensure the nebulizer cup is properly locked after adding medication to prevent leakage.
This recall applies to Hillrom VOLARA System P.CIRCUIT 5KIT AC (model REF M08474) distributed starting April 28, 2025. Check your device model and distribution date.
The recall does not require immediate removal. Check that the nebulizer cup is properly locked after adding medication to prevent leakage.
Yes, but you must ensure the nebulizer cup is properly locked after adding medication to prevent air and medication leakage.
We’ve drafted a message you can send Hillrom to request your refund or repair — edit it as you like.
Subject: Recall Z-2551-2026 — Hillrom Hillrom Hello, I own a Hillrom that is covered by recall Z-2551-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
