CLASS I ONGOING Device recall · Reported 8 Jul 2026 · FDA Enforcement Report
Hillrom Volara System P.Circuit Kit (Single Patient Use Circuit) recalled
Baxter Healthcare is recalling Hillrom Volara System P.Circuit Kit (Single Patient Use Circuit), distributed nationwide in the US. The recall was initiated on 21 May 2026 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2548-2026
- FDA event ID
- 99119
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 21 May 2026
- FDA classified
- 1 Jul 2026
- Reported
- 8 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 21 May 2026 | Recall initiated by company | |
| 1 Jul 2026 | Classified by FDA | +41 days |
| 8 Jul 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
Where it was distributed
Worldwide distribution - US Nationwide and the country of Canada.
Questions about this recall
Why was it 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.
Which lots are affected?
UDI: 00887761985018, Lot Numbers: All lot numbers distributed beginning on 4/28/2025
Where was it sold?
Worldwide distribution - US Nationwide and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 99119This product is part of a recall event; the main page for the event is Hillrom Volara System P.Circuit Kit AC (Single Patient Use Circuit) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Hillrom Volara System P.Circuit Kit AC (Single Patient Use Circuit) recalled | Baxter Healthcare | Packaging Defects | Nationwide | |
| CLASS I | Hillrom Volara System P.Circuit 5KIT AC recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide | |
| CLASS I | Hillrom Volara P.Circuit 5KIT (System Single Patient Use Circuit) recalled | Baxter Healthcare | Packaging Defects | Nationwide |
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