CLASS II Device recall · Reported 29 Dec 2021 · FDA Enforcement Report

VirtuTRAX Instrument Navigator, Sensor with VirtutTRAX recalled

Civco Medical Instruments is recalling VirtuTRAX Instrument Navigator, Sensor with VirtutTRAX, distributed nationwide in the US. The recall was initiated on 8 Oct 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number 5350925; UDI 00841436100892; Lot Numbers: A117795, A119539, A121993, A129844, A131074, A131075, A131690, A142178

Quantity recalled52 boxes (5 units/box)

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-0395-2022
FDA event ID: 88906
Recalling firm: Civco Medical Instruments, Kalona, IA
Classification: Class II
Status: Terminated
Recall initiated: 8 Oct 2021
FDA classified: 20 Dec 2021
Reported: 29 Dec 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

8 Oct 2021	Recall initiated by company
20 Dec 2021	Classified by FDA	+73 days
29 Dec 2021	Published in enforcement report	+9 days

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

Reason for recall

There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China (Mainland), China (Taiwan), Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Thailand.

Nationwide

Questions about this recall

Why was it recalled?

There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

Which lots are affected?

Part Number 5350925; UDI 00841436100892; Lot Numbers: A117795, A119539, A121993, A129844, A131074, A131075, A131690, A142178

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 88906

This product is part of a recall event; the main page for the event is VirtuTRAX Instrument Navigator VirtuTRAX recalled.

Reported	Class	Recall	Company	Reason	Where
29 Dec 2021	CLASS II	VirtuTRAX Instrument Navigator VirtuTRAX recalled	Civco Medical Instruments	Other	Nationwide
29 Dec 2021	CLASS II	VirtuTRAX Instrument Navigator, 10 VirtuTRAX recalled	Civco Medical Instruments	Other	Nationwide
29 Dec 2021	CLASS II	VirtuTRAX Instrument Navigator, Sensor with 10 VirtutTRAX recalled	Civco Medical Instruments	Device Malfunction	Nationwide

More recalls from Civco Medical Instruments

All 45

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS II	eTRAX Needle System Starter Kit (for Aurora Trackers) recalled	Civco Medical Instruments	Processing Deviation	OH, PA, WA
8 Apr 2026Device	CLASS II	eTRAX Needle Sensor -(for Aurora Trackers) recalled	Civco Medical Instruments	Processing Deviation	OH, PA, WA
8 Apr 2026Device	CLASS II	eTRAX Needle Sensor - (for Aurora Trackers) recalled	Civco Medical Instruments	Processing Deviation	OH, PA, WA
8 Apr 2026Device	CLASS II	eTRAX Needle System Starter Kit (for Aurora Trackers) recalled	Civco Medical Instruments	Processing Deviation	OH, PA, WA
8 Apr 2026Device	CLASS II	eTRAX Needle Sensor -(for Aurora Trackers) recalled	Civco Medical Instruments	Processing Deviation	OH, PA, WA

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All 13,884

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7 Oct 2026Device	CLASS II	Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire	Percussionaire	Other	Nationwide