FDA Recall of eTRAX Needle System Starter Kit 16G Announced

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. is voluntarily recalling 18 units of the eTRAX Needle System Starter Kit 16G due to a potential 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 14, 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.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

Recall Article

What Happened

Civco Medical Instruments Co. Inc. is recalling the eTRAX Needle System Starter Kit 16G due to an error in inspection and programming of the needle sensor, which may 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 16G (for Aurora Trackers), with Part Number 667-151. A total of 18 units are involved, distributed to US States: OH, PA, WA, and China. The products have UDI-DI: 00841436111058 and Lot Numbers: A228675, A228676, A233854, A268115, A268237, A272509, A277538, A280341.

What You Should Do

Consumers with the affected product should contact Civco Medical Instruments Co. Inc. for instructions on the recall. Refer to the FDA for the official recall notice using Recall Number Z-1733-2026.

Why This Matters

This recall involves a potential issue with medical device accuracy that could impact procedures, emphasizing the need for reliable equipment in healthcare settings.

Source

FDA Recall Number: Z-1733-2026. For more details, refer to the FDA website.

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. is voluntarily recalling 18 units of the eTRAX Needle System Starter Kit 16G due to a potential 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.