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eTRAX Needle System Starter Kit 12G
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MEDICAL DEVICE RECALLMODERATE

eTRAX Needle System Starter Kit 12G

Civco recalls eTRAX Needle System Starter Kit 12G (Part 667-149) due to sensor programming error causing incorrect needle tip position.

What to do

Stop using the affected eTRAX Needle System Starter Kit 12G immediately. Contact Civco Medical Instruments for instructions on returning the product and obtaining a replacement or correction.

Recalled
Listed
Updated
Recall No.
Z-1731-2026
Agency
FDA
Firm
Civco Medical Instruments Co. Inc.
Recall ID
98513
Status
ONGOING

Why it was recalled

Civco Medical Instruments is recalling the eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149, due to an error in inspection and programming of the eTRAX needle sensor. This error may cause the needle tip position to be incorrectly identified on the user interface, potentially leading to misplacement during procedures.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductRecall #UDI-DI
eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152Z-1734-202600841436111065
eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150Z-1732-202600841436111041
eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157Z-1736-202600841436111089
eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159Z-1738-202600841436111102
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151Z-1733-202600841436111058
eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158Z-1737-202600841436111096
eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149Z-1731-202600841436111034
eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156Z-1735-202600841436111072

Where it was sold

Distributed in Ohio, Pennsylvania, and Washington.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-08-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification