FDA Class I recall: air and medication leaking from the nebulizer cup on VOLARA respiratory therapy circuits (Baxter)
The U.S. FDA classified Baxter's single-patient-use circuits for the Hillrom VOLARA system as a Class I recall, its most serious category, following reports of air and medication leaking from the nebulizer cup during therapy. The recall covers 13,881 units distributed in the United States and Canada.
Recall overview (primary data)
- ClassificationClass I (most serious)
- Product typeMedical Device
- Recalling firmBaxter Healthcare Corporation
- ReasonThere 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.
- DistributionWorldwide distribution - US Nationwide and the country of Canada.
- Recall initiated2026-05-21
Key points
- The FDA classified it Class I, its most serious category (Z-2551-2026, reported July 8, 2026, status ongoing).
- The recall covers 13,881 Hillrom VOLARA System P.CIRCUIT 5KIT AC units (REF M08474), distributed in the United States and Canada.
- Air and medication have been reported leaking from the nebulizer cup during therapy, which can lower the patient's oxygen level and cause ineffective nebulization.
- FDA records associate the issue with the nebulizer cup not being properly locked after medication is added.
- The affected scope is UDI 10887761981499 and all lot numbers distributed beginning April 28, 2025.
1How VOLARA and its patient circuit work
VOLARA is a respiratory therapy device that combines oscillation with positive pressure to expand the lungs while also delivering medication as a mist for inhalation. It is used for patients who have difficulty clearing secretions or whose lungs do not expand adequately.
The patient circuit is the set of tubing and parts connecting the device to the patient, and the nebulizer cup within it is the container that holds and aerosolizes the medication to be inhaled.
2Two consequences of the leak
The reported defect is that air and medication leak from this nebulizer cup during therapy. FDA records identify two consequences. One is a drop in the patient's oxygen level, because air meant to expand the lungs under positive pressure escapes along the way.
The other is ineffective nebulization: medication that should be aerosolized and reach the lungs is lost to the leak, so the prescribed treatment does not arrive in the intended amount.
3Not a broken part, but a setup step
What makes this case notable is that FDA records associate the issue with improper locking of the nebulizer cup after adding medication during user setup. Rather than a straightforward component failure, the condition for the defect involves a step in the assembly sequence that is easy to leave incomplete.
It is an example of how device safety rests not only on materials and strength but also on design factors — usability and human factors — that determine whether anyone can assemble the device correctly in a busy clinical setting.
4Why it matters
The quantity is 13,881 units, distributed across the United States and Canada. Single-patient-use circuits are consumables replenished continuously, so stock tends to be dispersed across a facility, making affected lots comparatively laborious to identify and swap. FDA records state that the affected scope is UDI 10887761981499 and all lot numbers distributed beginning April 28, 2025.
Why it matters
Single-patient-use circuits are consumables replenished continuously and stored in several places within a facility, which makes identifying and swapping affected lots laborious. What further distinguishes this case is that the cause is associated with a setup step — the nebulizer cup not being locked properly — rather than a broken part, so both training and procedure updates and design improvement fall within scope. It illustrates why human-factors validation belongs in device design verification.
FAQ
What is a nebulizer cup?
What effects are described?
How is affected stock identified?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: Z-2551-2026