FDA Recall of eTRAX Needle System Starter Kit
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
The FDA has announced a voluntary recall of 20 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 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
The recall was initiated because of an error in the inspection and programming of the eTRAX needle sensor for Aurora trackers, 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 18G (for Aurora Trackers), with Part Number 667-152. A total of 20 units are involved, with Lot Numbers: A233347, A228677, A268116, A268238, A272513, A279457, A280388, and A281840. The product has UDI-DI: 00841436111065. Distribution occurred in US states including OH, PA, and WA, as well as China. The recall number is Z-1734-2026.
What You Should Do
Consumers who have the affected products should contact the recalling firm, Civco Medical Instruments Co. Inc., for further instructions, as this is a voluntary firm-initiated recall.
Why This Matters
This recall affects medical devices that could lead to inaccurate positioning in procedures, potentially posing risks to patient safety in the affected regions.
Source
According to the FDA recall notice with event ID 98513.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,121 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 14, 2026.
Frequently Asked Questions
Common questions about this FDA recall.