FDA-Device2026-04-08Class IIPROCESSING DEFECT
Civco eTRAX Needle Sensor 14G recalled for incorrect needle tip positioning
Stop using Civco eTRAX Needle Sensor 14G
Civco Medical Instruments discovered a programming error in certain eTRAX Needle Sensors (14G) used with Aurora Trackers. This error can cause the needle tip position to display incorrectly on the screen, which may affect accurate needle placement during procedures.
- Stop using eTRAX Needle Sensor 14G, Part Number 667-157 (Lot A276633, UDI-DI 00841436111089)
- Contact Civco Medical Instruments for instructions on returning or replacing the affected sensors
- If you have questions about whether your unit is affected, check the lot number on your packaging
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
5 units
Manufactured in
102 1st St S, Kalona, IA, United States
Products
eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1736-2026More 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 Sensor 18G recalled for incorrect position display
- FDA-Device2026-04-08Civco eTRAX Needle System Starter Kit recalled for incorrect needle tip position display
- 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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