FDA recall Z-0031-2026

Percussionaire Corporation · Class I · device

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2025-09-17
Report date: 2025-10-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Sandpoint, ID, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0031-2026