FDA-Device2026-04-08Class IIPROCESSING DEFECT
Civco eTRAX Needle System Starter Kit recalled for incorrect needle tip position display
Stop using Civco eTRAX Needle System Starter Kit
Civco Medical Instruments identified a programming error in certain eTRAX needle sensors used with Aurora trackers. This error can cause the needle tip position to display incorrectly on the user interface, which may affect the accuracy of needle placement guidance.
- Check if your eTRAX Needle System Starter Kit (Part Number 667-151) matches one of the affected lot numbers: A228675, A228676, A233854, A268115, A268237, A272509, A277538, or A280341
- Stop using the device if your lot number is listed
- Contact Civco Medical Instruments for instructions on replacement or correction
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
18 units
Manufactured in
102 1st St S, Kalona, IA, United States
Products
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1733-2026More 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 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
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief