# FDA recall Z-0960-2025

> **Percussionaire Corporation** · Class I · device recall initiated 2024-12-23.

## Product

VDR4 Phasitron Breathing Circuit Models that contain the venturi component:  -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk  -A51001, VDR4  Control Unit Tester  -PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON  -PRT 992, VDR4 HUMIDIFICATION ADAPTER KIT, CASE OF 10  -PRT 993, VDR4 Humidification Kit with Cross Tee, Case of 10    The Phasitron breathing circuit kit is intended to be used for  continuous ventilation intended for controlled ventilation of patients

## Reason for recall

Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.

## Distribution

Worldwide - U.S. Nationwide distribution in the states of AZ, FL, IL, MS, MO, NE, NJ, NY, NC, RI, TX, UT, and WV. The countries of Belgium, Canada, France, Hong Kong, Netherlands, Russia, Switzerland and Turkey.

## Key facts

- **Recall number:** Z-0960-2025
- **Recalling firm:** Percussionaire Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-23
- **Report date:** 2025-01-29

- **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-0960-2025

## Citation

> AI Analytics. FDA recall Z-0960-2025. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0960-2025. Source: US FDA. Licensed CC0.

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