# FDA recall Z-0031-2026

> **Percussionaire Corporation** · Class I · device recall initiated 2025-09-17.

## 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

- **Recall number:** Z-0031-2026
- **Recalling firm:** Percussionaire Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-17
- **Report date:** 2025-10-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sandpoint, ID, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0031-2026. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0031-2026. Source: US FDA. Licensed CC0.

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