Hillrom VOLARA System P
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.
- Agency
- FDA Device
- Recall date
- May 21, 2026
- Status
- Ongoing
- Company
- Baxter Healthcare Corporation
1. What product was recalled?
Hillrom VOLARA P
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
Quantity: 0
Code or lot text: UDI: 10887761985015; Lot Numbers: All lot numbers distributed beginning on 4/28/2025
- LOT
- Lot Numbers: All lot numbers distributed beginning on 4/28/2025
- LOT
- UDI: 10887761985015
- RECALL-NUMBER
- Z-2549-2026
Hillrom VOLARA System P
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
Quantity: 10540 units
Code or lot text: UDI: 00887761985018, Lot Numbers: All lot numbers distributed beginning on 4/28/2025
- LOT
- Lot Numbers: All lot numbers distributed beginning on 4/28/2025
- LOT
- UDI: 00887761985018
- RECALL-NUMBER
- Z-2548-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
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.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. The Recall Guy's urgency label is urgent, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
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10. Where is the official source?
Open the official FDA Device source
The Recall Guy normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.