FDA recall, , High risk
Hillrom Volara Circuit Kits
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits.
Summary by Recall Canary from the FDA notice
What happened
Baxter Healthcare Corporation, located in Deerfield, Illinois, recalled certain Hillrom Volara System patient circuit kits because of reports of air and medication leakage from the nebulizer cup during therapy. 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.
The recall began May 21, 2026, and was added to the FDA's Enforcement Report on July 1, 2026. The products were distributed nationwide in the US and in Canada.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
4 products
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Hillrom VOLARA System P.circuit Kit AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device
- UDI-DI
- 00887761981492
- Lot code
- All lot numbers distributed beginning on 4/28/2025
Hillrom VOLARA System P.circuit 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
- UDI-DI
- 10887761981499
- Lot code
- All lot numbers distributed beginning on 4/28/2025
Hillrom VOLARA P.circuit 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
- UDI-DI
- 10887761985015
- Lot code
- All lot numbers distributed beginning on 4/28/2025
Hillrom VOLARA System P.circuit Kit (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
- UDI-DI
- 00887761985018
- Lot code
- All lot numbers distributed beginning on 4/28/2025
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the country of Canada.
- Company
- Baxter Healthcare CorporationDeerfield, Illinois
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 99119
- Recall numbers
- Z-2548-2026 to Z-2551-2026
All recalls from Baxter Healthcare Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
