Hillrom VOLARA System P.CIRCUIT KIT Medical Device Recall for Oxygen Drop Risk
Baxter Healthcare is recalling the Hillrom VOLARA System P.CIRCUIT KIT (Model REF M08085) due to reports of air and medication leakage from the nebulizer cup, which can cause oxygen level drops and reduce treatment effectiveness.
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: The source indicates this is an FDA Class I recall for a medical device. Per the severity rubric, FDA Class I recalls are scored at minimum 4 (Severe), regardless of whether illnesses have been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling the Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085, a positive pressure breathing device used for oscillation lung expansion therapy. The recall affects approximately 10,540 units distributed worldwide, including nationwide in the United States and Canada.
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 leakage can lead to a drop in the patient's oxygen level and ineffective nebulization, which may prevent the prescribed treatment from being delivered properly.
Healthcare providers and patients using this device should verify that the nebulizer cup is properly locked after adding medication. For specific instructions on the recall and next steps, contact Baxter Healthcare Corporation. The recall applies to all lot numbers distributed beginning on April 28, 2025 (UDI: 00887761985018).
The recalled product
- Product
- Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- oxygen-deprivation
- medication-leakage
- treatment-failure
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: 00887761985018
- Lot Numbers: All lot numbers distributed beginning on 4/28/2025
Distribution
Distributed nationwide across the United States.
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