Recall of eTRAX Needle System Starter Kit by Civco Medical Instruments

Source: FDA · United States (OH, PA, WA) and China

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Civco Medical Instruments Co. Inc. has initiated a voluntary recall of 2 units of the eTRAX Needle System Starter Kit due to an error in needle sensor programming that could lead to incorrect needle tip identification.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 16, 2026 and geographically references United States (OH, PA, WA) and China. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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Recall Article

What Happened

Civco Medical Instruments Co. Inc. is recalling the eTRAX Needle System Starter Kit due to an error in the inspection and programming of the needle sensor, which could result in the needle tip position being incorrectly identified on the user interface.

Which Products Are Affected

The affected product is the eTRAX Needle System Starter Kit 12G (for Aurora Trackers), with Part Number 667-149. A total of 2 units are involved, identified by UDI-DI: 00841436111034 and Lot Number: A228672. These products were distributed to Ohio, Pennsylvania, and Washington in the United States, as well as China.

What You Should Do

Consumers who have the affected product should stop using it immediately and contact Civco Medical Instruments Co. Inc. at their address: 102 1st St S, Kalona, IA 52247-9589 for information on returns or refunds.

Why This Matters

This recall highlights the potential for errors in medical devices that could affect procedure accuracy, underscoring the need for reliable equipment in healthcare settings.

Source

FDA Recall Notice: Z-1731-2026

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Civco Medical Instruments Co. Inc. has initiated a voluntary recall of 2 units of the eTRAX Needle System Starter Kit due to an error in needle sensor programming that could lead to incorrect needle tip identification.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States (OH, PA, WA) and China. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.