Baxter Healthcare Corporation: Device, Positive Pressure Breathing, Intermittent
Recall Summary Baxter Healthcare is recalling Hillrom VOLARA P.CIRCUIT 5KIT positive pressure breathing devices because the nebulizer cup may not lock properly after medication is added, causing air and medication to leak during treatment. This leakage can result in lower oxygen levels for the patient and prevent the medication from being delivered effectively. The recall affects devices distributed nationwide in the US and in Canada.
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; 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/66590917-2721-4dd3-9e3f-cbc4b15f7c2b