FDA-Device2026-04-08Class IIPROCESSING DEFECT

Civco eTRAX Needle Sensor for Aurora Trackers recalled for incorrect needle position display

OTHEROHPAWA

Stop using Civco eTRAX Needle Sensor

Civco Medical Instruments has recalled certain eTRAX Needle Sensors (16G, Part Number 667-158) used with Aurora Trackers due to a programming error during manufacturing. The sensor may display an incorrect needle tip position on the user interface, which could affect proper guidance during procedures. The recall affects 10 units distributed in Ohio, Pennsylvania, Washington, and China.

  • Stop using the affected eTRAX Needle Sensor immediately if you have one from lot numbers A276636 or A282454
  • Contact Civco Medical Instruments for instructions on return or replacement
  • Review any recent procedures performed with this sensor and consult with your clinical team if needed
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
10 units
Manufactured in
102 1st St S, Kalona, IA, United States
Products
eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1737-2026

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