Quick Facts at a Glance
- Recall Date
- May 21, 2026
- Hazard Level
- HIGH
- Brand
- Baxter Healthcare
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Baxter Healthcare
- Model numbers
- UDI: 00887761981492, Lot Numbers: All lot numbers distributed beginning on 4/28/2025
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 21, 2026
Reported by FDA DEVICE
July 8, 2026
RecallRadar source check
July 14, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Baxter Healthcare Corporation or your healthcare provider for instructions. Notification method: Letter
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Full Description
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. Quantity: 16187 units. Distribution: Worldwide distribution - US Nationwide and the country of Canada.
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Safety Guide
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