Baxter Healthcare Corporation recalls Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit)

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.

Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device

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. Additional patient circuits can be provided through standard distribution. 3. If you received this communication directly from Baxter, please acknowledge receipt of this notification by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com, even if you do not have any remaining inventory. Log in to the portal using the account number listed in the enclosed reply instruction sheet. Acknowledging receipt of this notification will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from Accenture LLP on behalf of Baxter to confirm your receipt of this notification. 4. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to the supplier according to their instructions. 5. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this urgent medical device correction in accordance with your customary procedures and check the associated box

• FDA enforcement recordOfficial FDA database entry for Z-2548-2026
• FDA 510(k) clearance · K192143The device's official FDA premarket clearance record
• FDA 510(k) clearance · K200988The device's official FDA premarket clearance record
• FDA device classification · NHJOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5905The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Baxter Healthcare CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.