Baxter Healthcare Corporation: Device, Positive Pressure Breathing, Intermittent
Recall Summary Baxter Healthcare is recalling the Hillrom VOLARA System P.CIRCUIT KIT AC, a positive pressure breathing device used for lung expansion therapy. The nebulizer cup can leak air and medication if not properly locked during setup, which may cause oxygen levels to drop and prevent effective medication delivery to patients. The recall affects devices distributed nationwide in the US and Canada.
- Recalling firm
- 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 II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-21
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/d5edd7b5-1bce-41a9-a1ab-305efad15138