Data Foundry

Medical device recalls 2025

VDR4 Phasitron Breathing Circuit Models that contain the venturi… — Class I medical device recall Z-0960-2025

Ongoing recall by Percussionaire Corporation, reported 2025-01-29, distributed nationwide. Due to internal venturi component getting transiently stuck in the forward position within the breathing circu

Recall numberZ-0960-2025
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmPercussionaire Corporation, Sandpoint, ID, United States
Recall initiated2024-12-23
Classified2025-01-23
Reported by FDA2025-01-29
DistributedNationwide (US)
Countries outside the USBE, CA, CH, FR, HK, NL, RU, TR
Quantity4,727 packages
UPC / GTIN / UDI-DI00849436000259
Lot numbersVDR4, WO04294, WO04424, WO045667, WO04733, WO04745, WO04750, WO04764, WO04832, WO04893, WO05070, WO05186, WO05309, WO05460, WO05685, WO05910, WO06388, WO06523, WO06576, WO06701VDR, WO06883, WO07080, WO07095, WO07196, WO07283, WO07317, WO07405, WO07450, WO07696
Model numbers991, 992, 993, A50094-D-5PK, A51001, VDR4

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0960-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.