Recall Z-2551-2026 ยท NHJ Device, Positive Pressure Breathing, Intermittent
Baxter Healthcare Corporation
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
| Date | Jul 1, 2026 (initiated May 21, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | Baxter issued an URGENT MEDICAL DEVICE CORRECITON notice to its consignees on 5/21/2026 via USPS first class mail. The notice explained the issue, hazard involved, and requested the following: "Actions to be Taken by Customers 1. Before each use, carefully inspect the nebulizer cup for damage and ensure it is fully and securely locked during assembly, following the enclosed instructions. If leakage is observed during therapy, discontinue the use of that nebulizer and replace the patient circuit. 2. Nebulizer cups with patient circuits are routinely replaced as part of normal therapy usage |
| Quantity | 13881 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |