Baxter Healthcare Corporation: Device, Positive Pressure Breathing, Intermittent

Recall Summary Baxter Healthcare is recalling the Hillrom VOLARA System P.CIRCUIT 5KIT AC, a positive pressure breathing device used for lung expansion therapy. The nebulizer cup can leak air and medication during treatment if not properly locked after medication is added, which may reduce oxygen levels and prevent proper medication delivery to the patient. The recall affects devices distributed nationwide in the US and Canada.

Recalling firm

Baxter Healthcare Corporation

Product

Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; 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/0606cf55-3027-42bc-83e3-aa06fe4d4c17