FDA Device recall Z-2548-2026
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085
- FDA Device
- Class I
- ongoing
- Published 2026-07-08
On 2026-07-08 the FDA classified a Class I recall of Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085 by Baxter Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2548-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-05-21 |
| Published | 2026-07-08 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
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.
Identifiers
| code_info | UDI: 00887761985018, Lot Numbers: All lot numbers distributed beginning on 4/28/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2548-2026%22
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