Positive Pressure Breathing Device Correction

1 recall on record · Last recall: Jul 14, 2026

Safety Score

97/100

Excellent

Based on recall frequency and severity over the past 3 years, with older recalls weighted less.

Severity Breakdown

Class I — Serious

Class II — Moderate

Class III — Low Risk

Unclassified

Recall Timeline

FDAJul 14, 2026

Positive Pressure Breathing Device Correction: Baxter Issues Correction for Volera Positive Pressure Breathing Devices

Volara system patient circuits may leak air and medication from the nebulizer cup during therapy, leading to reduced oxygenation and ineffective nebulization.

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