← FDA ENFORCEMENT
Z-1738-2026Class II

Civco Medical Instruments Co. Inc.

Recalling firm
Civco Medical Instruments Co. Inc.
Product type
Device
Status
Ongoing
Report date
2026-04-08
Distribution
US States: OH, PA, WA. China.
Firm state
IA
Product quantity
21 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
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.

Product description

eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159

Code / lot info

UDI-DI: 00841436111102; Lot Number: A257459, A252198, A268105, A276632

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.