FDA-Device2026-04-08Class IIPROCESSING DEFECT
Civco eTRAX Needle Sensor 18G recalled for incorrect position display
Stop using affected Civco eTRAX needle sensors
Civco Medical Instruments Co. Inc. is recalling certain eTRAX Needle Sensor 18G units used with Aurora Trackers due to an inspection and programming error. This error can cause the needle tip position to display incorrectly on the user interface, potentially affecting procedure guidance.
- Check if you have an affected eTRAX Needle Sensor (Part Number 667-159) from one of these lot numbers: A257459, A252198, A268105, or A276632
- Stop using the affected sensor immediately
- Contact Civco Medical Instruments Co. Inc. for instructions on replacement or return
Hazard
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Sold states
US States: OH, PA, WA. China.
Affected count
21 units
Manufactured in
102 1st St S, Kalona, IA, United States
Products
eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1738-2026More Civco Medical Instruments Co. Inc. recalls
- FDA-Device2026-04-08Civco eTRAX Needle System Starter Kit recalled for inaccurate needle position display
- FDA-Device2026-04-08Civco eTRAX Needle System Starter Kit recalled for incorrect needle tip position display
- FDA-Device2026-04-08Civco eTRAX Needle Sensor 14G recalled for incorrect needle tip positioning
- FDA-Device2026-04-08Civco eTRAX Needle System Starter Kit recalled for incorrect needle position display
- FDA-Device2026-04-08Civco eTRAX Needle Sensor 12G recalled for incorrect needle tip positioning
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