Early Alert: Positive Pressure Breathing Device Issue From Baxter
Baxter Positive Pressure Breathing Device Recall Baxter is recalling Volara system patient circuits because they may leak air and medication from the nebulizer cup during use, which can reduce oxygen delivery and prevent proper medication delivery to patients. The issue affects users of the Volara positive pressure breathing device system. This is an early alert, meaning more details about the recall may be released as the investigation continues.
- Recalling firm
- Baxter
- Product
- Positive Pressure Breathing Device
- Reason
- Volara system patient circuits may leak air and medication from the nebulizer cup during therapy, leading to reduced oxygenation and ineffective nebulization.
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-MEDWATCH-RSS
- Recall date
- 2026-06-11
- Status
- Ongoing
Official recall notice from FDA-MEDWATCH-RSS
Recall details on Nibble Recalls: https://trynibble.app/recalls/416b77d0-265e-4ced-abdb-b392e96c340f