Recall of eTRAX Needle Sensor by Civco Medical Instruments
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Civco Medical Instruments Co. Inc. is recalling 21 units of the eTRAX Needle Sensor - 18G due to an error in inspection and programming that may cause 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.
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Recall Article
What Happened
Civco Medical Instruments Co. Inc. is recalling the eTRAX Needle Sensor due to an error in inspection and programming, 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 Sensor - 18G (for Aurora Trackers), with Part Number 667-159. A total of 21 units are involved, distributed to US states including OH, PA, and WA, as well as China. The recall includes UDI-DI: 00841436111102 and Lot Numbers: A257459, A252198, A268105, A276632.
What You Should Do
Consumers and users should contact Civco Medical Instruments Co. Inc. at their address, 102 1st St S, Kalona, IA 52247-9589, for information on the recall, as it is a voluntary firm-initiated action.
Why This Matters
This recall highlights potential risks in medical device accuracy, which could affect patient safety in the regions where the products were distributed.
Source
FDA recall notice Z-1738-2026. Attribution: FDA.
Original source: FDA Official Notice ↗
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