eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
Summary
The FDA issued a Class II for eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159 by Civco Medical Instruments Co. Inc.. 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.
Details
Source
Device Recall
External ID
Z-1738-2026
Action Date
2026-04-08
Status
Ongoing
Category
device
Product Description
eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
Lot/Code Info: UDI-DI: 00841436111102; Lot Number: A257459, A252198, A268105, A276632
Quantity Affected: 21 units
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.
Distribution
US States: OH, PA, WA. China.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-02
Company
Kalona, IA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 252 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Civco Medical Instruments Co. Inc. has 16 FDA actions in our database, including 13 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Civco Medical Instruments Co. Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Civco Medical Instruments Co. Inc. have FDA actions?
Civco Medical Instruments Co. Inc. has 16 FDA actions in our database, including 13 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1738-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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