FDA Recall of Civco Medical's eTRAX Needle Sensor
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The FDA has issued a recall for 5 units of the eTRAX Needle Sensor due to a programming error 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 15, 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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What Happened
Civco Medical Instruments Co. Inc. is recalling the eTRAX Needle Sensor because of 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 - 14G (for Aurora Trackers), with Part Number 667-157. The recall involves 5 units, identified by UDI-DI: 00841436111089 and Lot Number: A276633. These products were distributed to US States: OH, PA, WA, and China.
What You Should Do
Individuals with the affected product should stop using it and contact the recalling firm, Civco Medical Instruments Co. Inc., for further instructions regarding returns or refunds.
Why This Matters
This recall highlights potential risks in medical devices that could lead to inaccurate procedures, affecting patient safety in a limited number of units.
Source
FDA Recall Number: Z-1736-2026. For more information, visit the FDA website at https://www.fda.gov.
Original source: FDA Official Notice ↗
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