Class I — Percussionaire Corporation
| Recalling firm | PERCUSSIONAIRE CORP. |
|---|---|
| Registered facility | PERCUSSIONAIRE CORP. (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | 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. |
| 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 |
| Quantity | 4,727 packs/cases |
| 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. |
| Initiated | 2024-12-23 |
| Classified | 2025-01-23 |
| Recall number | Z-0960-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Percussionaire Corporation (Z-0960-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95979/
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