CLASS I ONGOING Device recall · Reported 29 Jan 2025 · FDA Enforcement Report

VDR4 Phasitron Breathing Circuit recalled by Percussionaire

Percussionaire is recalling VDR4 Phasitron Breathing Circuit, distributed nationwide in the US. The recall was initiated on 23 Dec 2024 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codes-Phasitron Kit, VDR, Single Patient, 5pk Model Number - A50094-D-5PK UDI-DI code: 00849436000259 Lot Codes: WO04294 WO04424 WO04764 WO05070 WO05186 WO05460 WO05685 WO05910 WO06388 WO06576 WO06883 WO07095 WO07196 WO07317 WO07405 WO07450 WO07696 - Control Unit Tester Model Number: A51001 VDR4 Lot Codes: WO04750 WO06701 - VDR W/Swivel T Single Patient Phasitron Model Number: PRT 991 Lot Code: WO04733 - VDR4 Humidification Adapter Kit, Case of 10 Model Number: PRT 992 Lot Code: WO045667 - VDR4 Humidification Kit with Cross Tee, Case of 10 Model Number: PRT 993 Lot Codes: WO04745 WO04832 WO04893 WO04893 WO05309 WO06523 WO07080 WO07283

Quantity recalled4,727 packs/cases

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0960-2025
FDA event ID: 95979
Recalling firm: Percussionaire, Sandpoint, ID
Classification: Class I
Status: Ongoing
Recall initiated: 23 Dec 2024
FDA classified: 23 Jan 2025
Reported: 29 Jan 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

23 Dec 2024	Recall initiated by company
23 Jan 2025	Classified by FDA	+31 days
29 Jan 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Arizona Florida Illinois Missouri Mississippi North Carolina Nebraska New Jersey New York Rhode Island Texas Utah West Virginia

Questions about this recall

Is VDR4 Phasitron Breathing Circuit recalled?

Yes. Percussionaire recalled VDR4 Phasitron Breathing Circuit on 23 Dec 2024. The recall is Class I and its status is Ongoing. Recall number Z-0960-2025.

Why was it recalled?

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.

Which lots are affected?

-Phasitron Kit, VDR, Single Patient, 5pk Model Number - A50094-D-5PK UDI-DI code: 00849436000259 Lot Codes: WO04294 WO04424 WO04764 WO05070 WO05186 WO05460 WO05685 WO05910 WO06388 WO06576 WO06883 WO07095 WO07196 WO07317 WO07405 WO07450 WO07696 - Control Unit Tester Model Number: A51001 VDR4 Lot Codes: WO04750 WO06701 - VDR W/Swivel T Single Patient Phasitron Model Number: PRT 991 Lot Code: WO04733 - VDR4 Humidification Adapter Kit, Case of 10 Model Number: PRT 992 Lot Code: WO045667 - VDR4 Humidification Kit with Cross Tee, Case of 10 Model Number: PRT 993 Lot Codes: WO04745 WO04832 WO04893 WO04893 WO05309 WO06523 WO07080 WO07283

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Percussionaire

All 8

Reported	Class	Recall	Company	Reason	Where
22 Oct 2025Device	CLASS I	Phasitron 5, IPV In-Line Valve recalled by Percussionaire	Percussionaire	Packaging Defects	Nationwide
6 Nov 2024Device	CLASS I	Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10) recalled	Percussionaire	Other	40 states
9 Oct 2024Device	CLASS I	Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV recalled	Percussionaire	Other	Nationwide
9 Oct 2024Device	CLASS I	Percussionaire, Inc., REF: P5-Tee-20, Qty: 20, Rx Only. IPV recalled	Percussionaire	Other	Nationwide
24 Jan 2024Device	CLASS I	Distal Phasitron, Part: S20020, for use recalled by Percussionaire	Percussionaire	Other	CA, RI, TX

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