Recall Ledger

eTRAX Needle Sensor - 18G recall (Civco Medical Instruments Co. Inc.)

Medical deviceClass IIOngoing

Summary: Civco Medical Instruments Co. Inc. is recalling eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159. 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.

What is being recalled

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

Why

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.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

US States: OH, PA, WA. China. (states named: Ohio, Pennsylvania, Washington)

How to tell if yours is affected

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

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-1738-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedMarch 2, 2026
ReportedApril 8, 2026
CompanyCivco Medical Instruments Co. Inc.
Company locationKalona, IA, United States
Initiated byVoluntary: Firm initiated
Quantity21 units

More recalls from Civco Medical Instruments Co. Inc. · all medical device recalls · recalls from March 2026

Official FDA record