FDA DevicesClass I
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog ...
Published: July 8, 2026Recall ID: Z-2548-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
Additional Source Details
| Field | Value |
|---|---|
| City | Deerfield |
| State | IL |
| Event id | 99119 |
| Address 1 | 1 Baxter Pkwy |
| Address 2 | N/A |
| Code info | UDI: 00887761985018, Lot Numbers: All lot numbers distributed beginning on 4/28/2025 |
| Postal code | 60015-4625 |
| Report date | 20260708 |
| Product type | Devices |
| Product quantity | 10540 units |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260521 |
| Initial firm notification | Letter |
| Center classification date | 20260701 |
Overview
- Recalling FirmBaxter Healthcare Corporation
- StatusOngoing
- Risk LevelClass I
- DistributionWorldwide distribution - US Nationwide and the country of Canada.