Percussionaire Corporation recalls Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual…

Recall date

September 17, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0031-2026

FDA classification

Class I

Brand / firm

Percussionaire Corporation

Sold / distributed

Worldwide distribution. US nationwide, Russia, Japan, Switzerland, Canada, Qatar, Chile, South Africa, United Kingdom, Israel, Turkey, and UAE

Why it was recalled

IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use