Baxter Healthcare Corporation recalls Hillrom VOLARA System P.CIRCUIT KIT AC
- Recalling company
- Baxter Healthcare Corporation
- Product
- Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; 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.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- May 21, 2026
- Reported
- Jul 8, 2026
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Status
- Ongoing
- Quantity
- 16187 units
- Lot / codes
- UDI: 00887761981492; Lot Numbers: All lot numbers distributed beginning on 4/28/2025
- Company location
- Deerfield, IL
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2550-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2550-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.