Z-2549-2026Class I

Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270...

Name: Z-2549-2026 Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270...
Creator: Baxter Healthcare Corporation
Published: 2026-05-21
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2026-05-21 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure... on 2026-05-21. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2549-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-05-21
Posted: 2026-07-01
Recalling firm: Baxter Healthcare Corporation
Product: Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
Product code: NHJ Device, Positive Pressure Breathing, Intermittent
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.
Root cause tag: manufacturing process
FDA 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. 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
Quantity in commerce: 0
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: UDI: 10887761985015; Lot Numbers: All lot numbers distributed beginning on 4/28/2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2549-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2548-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01
Z-2549-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01
Z-2550-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01
Z-2551-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-07-01

Product code NHJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)