Hillrom VOLARA P.CIRCUIT Medical Device Nebulizer Cup Leakage Recall
Baxter Healthcare Corporation is recalling the Hillrom VOLARA P.CIRCUIT 5KIT medical device due to reports of air and medication leakage from the nebulizer cup, which can reduce oxygen levels and compromise medication delivery.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall for a respiratory medical device where the defect (leakage leading to oxygen level drop and treatment failure) poses serious risk to patient safety, meeting the Severe threshold for Class I with potential for significant harm even though no hospitalizations are explicitly reported in the source.
Plain-English summary
Baxter Healthcare Corporation is recalling the Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit, Model/Catalog Number REF M08270), an oscillation lung expansion therapy and positive pressure breathing device. The device has been distributed worldwide, including US Nationwide and Canada, beginning April 28, 2025.
Reports indicate that air and medication can leak from the nebulizer cup during therapy. The leakage occurs due to improper locking of the nebulizer cup after medication is added during user setup. This malfunction can result in decreased oxygen levels in the patient and ineffective nebulization, potentially compromising the delivery of prescribed treatment.
Patients and healthcare providers who have received or are using this device should contact Baxter Healthcare Corporation for guidance. The affected product is identified by UDI 10887761985015, and all lot numbers distributed beginning April 28, 2025 are included in this recall.
The recalled product
- Product
- Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- product-malfunction
- medication-leakage
- oxygen-deprivation-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 10887761985015
- Lot Numbers: All lot numbers distributed beginning on 4/28/2025
Distribution
Distributed nationwide across the United States.
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