CLASS II ONGOING Device recall · Reported 8 Apr 2026 · FDA Enforcement Report

eTRAX Needle System Starter Kit(for Aurora Trackers) recalled

Civco Medical Instruments Co is recalling eTRAX Needle System Starter Kit(for Aurora Trackers), distributed in Ohio, Pennsylvania, Washington. The recall was initiated on 2 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00841436111058; Lot Number: A228675, A228676, A233854, A268115, A268237, A272509, A277538, A280341

Quantity recalled18 units

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-1733-2026
FDA event ID: 98513
Recalling firm: Civco Medical Instruments Co, Kalona, IA
Classification: Class II
Status: Ongoing
Recall initiated: 2 Mar 2026
FDA classified: 1 Apr 2026
Reported: 8 Apr 2026
Type: Voluntary: Firm initiated
Reason category: Processing Deviation
Device type: Syringes & Needles

Timeline

2 Mar 2026	Recall initiated by company
1 Apr 2026	Classified by FDA	+30 days
8 Apr 2026	Published in enforcement report	+7 days

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

Reason for recall

There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.

Product as listed by the FDA

eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151

Where it was distributed

US States: OH, PA, WA. China.

Ohio Pennsylvania Washington

Questions about this recall

Is eTRAX Needle System Starter Kit(for Aurora Trackers) recalled?

Yes. Civco Medical Instruments Co recalled eTRAX Needle System Starter Kit(for Aurora Trackers) on 2 Mar 2026. The recall is Class II and its status is Ongoing. Recall number Z-1733-2026.

Why was it recalled?

Which lots are affected?

UDI-DI: 00841436111058; Lot Number: A228675, A228676, A233854, A268115, A268237, A272509, A277538, A280341

Where was it sold?

US States: OH, PA, WA. China.

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 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 Civco Medical Instruments Co

All 36

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

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