United StatesHillrom VOLARA System single‑patient use circuit kits for Oscillation Lung Expansion Therapy, model/catalog REF M08085, M08270, M08473, and M08474 (all lot numbers distributed beginning 4/28/2025) are affected; these units were distributed in the United States, Canada and worldwide. They were recalled after reports of air and medication leakage from the nebulizer cup during therapy that can cause a drop in patient oxygen levels and ineffective nebulization, an issue tied to improper locking of the nebulizer cup after adding medication during setup.
What's being recalled
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
Recalling firm: Baxter Healthcare Corporation, Deerfield, IL, United States.
How to identify it
UDI: 00887761985018, Lot Numbers: All lot numbers distributed beginning on 4/28/2025 UDI: 10887761985015; Lot Numbers: All lot numbers distributed beginning on 4/28/2025 UDI: 00887761981492; Lot Numbers: All lot numbers distributed beginning on 4/28/2025 UDI: 10887761981499; Lot Numbers: All lot numbers distributed beginning on 4/28/2025
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution - US Nationwide and the country of Canada.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)