Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0031-2026 — 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

U.S. FDA — Device Enforcement · United States · 2025-09-17 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0031-2026
Date of alert
2025-09-17
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Percussionaire Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00849436000723
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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