Critical Alert
Baxter Healthcare Corporation Recalls Hillrom VOLARA System P.CIRCUIT 5KIT AC
This is a Class I recall — the most serious type. There is a reasonable probability of serious health consequences or death.
Source: FDA
CriticalRecall #Z-2551-2026Medical Device
Baxter Healthcare Corporation Recalls Hillrom VOLARA System P.CIRCUIT 5KIT AC
Baxter Healthcare Corporation · Class I — Most Serious
Product Description
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
Reason for Recall
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.
FDA Classification
Class I — Most Serious
A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class I recall — the FDA's most urgent classification — has been issued for a medical device recalled by Baxter Healthcare Corporation on May 21, 2026. There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. This recall affects 13881 units and was distributed internationally, including the United States. Class I recalls indicate a reasonable probability of serious health consequences or death. Consumers should stop using this product immediately.
Sources: FDA openFDA Enforcement Database
This recall appears in: Medical Device Defects.