Hillrom VOLARA System patient circuits recalled for nebulizer cup leakage
Baxter Healthcare is recalling Hillrom VOLARA System patient circuits due to reports of air and medication leakage from the nebulizer cup, which can cause oxygen level drops and ineffective medication delivery.
The agency’s classification
FDA (Devices): Class I
Class I is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a medical device. Class I recalls are inherently classified as Severe or Critical per the rubric; the hazard involves potential oxygen level drops during therapy, which represents significant risk of harm to patients dependent on the device for breathing support.
Plain-English summary
Baxter Healthcare Corporation is recalling the Hillrom VOLARA System P.CIRCUIT 5KIT AC single-patient-use circuits (Model/Catalog Number REF M08474) distributed worldwide in the United States and Canada. The recall affects 13,881 units with all lot numbers distributed beginning April 28, 2025.
Reports indicate air and medication leakage from the nebulizer cup during therapy. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
Patients and healthcare providers currently using this device should contact Baxter Healthcare Corporation for instructions on how to proceed. The UDI for this product is 10887761981499.
The recalled product
- Product
- Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 13,881
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: 10887761981499
- Lot Numbers: All lot numbers distributed beginning on 4/28/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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