ProductGuru Recalls

Official recall record

Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy,

US FDA — Medical Devices · 2026-05-21 · United StatesClass I
Issuing authority
US FDA — Medical Devices
Recall initiated by firm
2026-05-21
Country of alert
United States
Alert level
Class I
Alert type
recall
Barcode (EAN/GTIN)
10887761981499
Brand on record
Baxter Healthcare Corporation
Product category
Medical Device

What the authority reported

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

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-16.

More recalls: US FDA — Medical Devices · United States · all filters

Other recalls from this brand

All 43 official recall notices naming Baxter Healthcare Corporation on this site →

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.