Volara System recallZ-2551-2026 · Baxter Healthcare Corporation · initiated May 21, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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
Recall details
- Recall number
- Z-2551-2026
- Status
- Open, Classified
- Initiated by the company
- May 21, 2026
- Posted by the FDA
- Jul 1, 2026
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 13881 units
- Product code
- NHJ
- FDA submissions
- K192143, K200988
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
Product description
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
Code information (models, lots, serial numbers)
UDI: 10887761981499; Lot Numbers: All lot numbers distributed beginning on 4/28/2025
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Volara System M08473Hill-Rom Services Pte. Ltd. · DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT3 recalls0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 99119).
- Z-2548-2026 · Open, ClassifiedHillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
- Z-2549-2026 · Open, ClassifiedHillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
- Z-2550-2026 · Open, ClassifiedHillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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