Baxter Healthcare Corporation medical device recall: Hillrom VOLARA System P.CIRCUIT KIT
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 99119
- Recall initiated
- May 21, 2026
- Classified by FDA
- Jul 1, 2026
- Posted in Enforcement Report
- Jul 8, 2026
- Recalling firm
- Baxter Healthcare Corporation
- Firm location
- Deerfield, IL, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 4
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on May 21, 2026. FDA classified it 41 days later, on Jul 1, 2026. This recall event covers 4 separate products, each with its own FDA recall number. Distribution reported by FDA: Worldwide distribution - US Nationwide and the country of Canada. Baxter Healthcare Corporation has 279 recalls in our records.
Recalled products (4)
Z-2548-2026 Class I Ongoing
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
Codes / lots: UDI: 00887761985018, Lot Numbers: All lot numbers distributed beginning on 4/28/2025
Quantity: 10540 units
Z-2549-2026 Class I Ongoing
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
Codes / lots: UDI: 10887761985015; Lot Numbers: All lot numbers distributed beginning on 4/28/2025
Quantity: 0
Z-2550-2026 Class I Ongoing
Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device
Codes / lots: UDI: 00887761981492; Lot Numbers: All lot numbers distributed beginning on 4/28/2025
Quantity: 16187 units
Z-2551-2026 Class I Ongoing
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
Codes / lots: UDI: 10887761981499; Lot Numbers: All lot numbers distributed beginning on 4/28/2025
Quantity: 13881 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 99119
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.