Recall of eTRAX Needle System Starter Kit by Civco Medical Instruments
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 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, cpsc, Devices.
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 ↗
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 (1,111 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 16, 2026.
Frequently Asked Questions
Common questions about this FDA recall.