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Hillrom Volara Patient Circuit Kit
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MEDICAL DEVICE RECALLCRITICAL

Hillrom Volara Patient Circuit Kit

Hillrom Volara circuit kits recalled over nebulizer cup leakage causing oxygen drops and ineffective treatment.

What to do

Stop using the recalled Volara System P.Circuit Kit immediately. Contact Baxter Healthcare Corporation for instructions on returning the product and obtaining a replacement.

Posted
Updated
Recall No.
Z-2550-2026
Agency
Firm
Baxter Healthcare Corporation
Recall ID
99119
Status
ONGOING

Why it was recalled

Baxter Healthcare Corporation is recalling Hillrom Volara System P.Circuit Kits (REF M08085) due to reports of air and medication leakage from the nebulizer cup during therapy. The leakage can cause oxygen level drops and ineffective nebulization, potentially affecting prescribed treatment delivery.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductUPCRecall #
Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device00887761981492Z-2550-2026
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device10887761981499Z-2551-2026
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device10887761985015Z-2549-2026
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device00887761985018Z-2548-2026

Where it was sold

Distributed nationwide.

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Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification