Hillrom recalls VOLARA System circuit kits with air and medication leaks that may cause oxygen drops. Affected units sold from 4/28/2025 onward; fix by ensuring nebulizer cup locks properly.
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 can leak air and medication during therapy, risking oxygen drops and ineffective treatment. Users should check if the nebulizer cup locks properly after adding medication.
The nebulizer cup can leak air and medication if not locked correctly after adding medication. This leakage may cause oxygen levels to drop and reduce the effectiveness of the prescribed treatment.
Patients using the Hillrom VOLARA System circuit kits for respiratory therapy are affected. Those who recently added medication to the nebulizer cup without proper locking are at higher risk.
Check for the model number REF M08085 on the circuit kit. Units were sold starting April 28, 2025, with a unique device identifier (UDI) starting with 00887761985018.
Ensure the nebulizer cup locks securely after adding medication during setup.
The recall addresses potential air and medication leaks that could cause oxygen drops, but the risk is not immediate unless the nebulizer cup is not locked properly after adding medication.
Look for the model number REF M08085 on the circuit kit. Units were sold starting April 28, 2025, with a unique device identifier (UDI) starting with 00887761985018.
Ensure the nebulizer cup locks securely after adding medication during setup. If leaks occur, contact Hillrom for further guidance.
We’ve drafted a message you can send Hillrom to request your refund or repair — edit it as you like.
Subject: Recall Z-2548-2026 — Hillrom Hillrom Hello, I own a Hillrom that is covered by recall Z-2548-2026 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.
