Recall Z-1734-2026— Civco Medical Instruments Co. Inc.

Name: FDA recall Z-1734-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-02

Class II · Ongoing

Class II FDA medical device recall by Civco Medical Instruments Co. Inc., initiated 2026-03-02. It names one FDA 510(k) clearance: K092619. Product: eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152. Reason: 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..

Recalling firm: Civco Medical Instruments Co. Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-03-02
Firm location: Kalona, IA, United States

510(k) clearances named in this recall

1 on FDA's record

K092619 — ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKERCivco·cleared 2009-11-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.