Baxter Healthcare Corporation: Device, Positive Pressure Breathing, Intermittent
Recall Summary Baxter is correcting Volera Positive Pressure Breathing Devices because patient circuits may leak air and medication from the nebulizer cup during use. This leakage can reduce oxygen delivery and prevent medication from being delivered effectively to patients. The correction affects users of Volera breathing devices.
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, HOMECARE, NORTH AMERICA Component: No
- Reason
- Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-03
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of Colorado and Florida.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/bf72f0ab-fe80-46c6-b72f-520292136c22