HIGH

Civco Medical Instruments Recalls 21 eTRAX Needle Sensors for Aurora Trackers (2026)

Civco Medical Instruments Co. recalled 21 eTRAX Needle Sensors for Aurora Trackers sold to healthcare providers in Ohio, Pennsylvania and Washington. The devices have an inspection and programming error that can cause the needle tip position to be misidentified on the user interface. Clinicians should stop using the devices immediately and follow recall instructions from Civco.

Quick Facts at a Glance

Recall Date
March 2, 2026
Hazard Level
HIGH
Brand
Civco Medical Instruments Co.
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
3 states
At-Risk Groups
GENERAL

Hazard Information

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 You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Civco Medical Instruments Co. Inc. or your healthcare provider for instructions

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About This Product

The eTRAX Needle Sensor is part of a medical device system used with Aurora Trackers to identify needle position during procedures. It is intended for professional clinical use.

Why This Is Dangerous

A misidentified needle tip on the user interface can lead to incorrect needle placement guidance, potentially affecting patient safety.

Industry Context

This recall is not described as part of a broader industry pattern in the provided information.

Real-World Impact

Clinicians administering procedures with the affected sensors may experience inaccurate needle guidance, which could compromise patient safety and workflow.

Practical Guidance

How to identify if yours is affected

  1. Check Part Number 667-159 on your device.
  2. Verify UDI-DI 00841436111102 on the label.
  3. Review Lot Numbers A257459, A252198, A268105, A276632.
  4. Confirm distribution states OH, PA, WA.
  5. If matched, stop using the device and contact Civco for instructions.

Where to find product info

Device label for Part Number 667-159 and UDI-DI 00841436111102; recall notice for distribution areas and lot numbers.

What timeline to expect

Remedy processing timelines are not specified; follow Civco recall instructions and watch for updates.

If the manufacturer is unresponsive

  • Contact Civco Customer Support and your equipment provider for escalation.
  • If you cannot reach Civco, file a report with the FDA recall system.

How to prevent similar issues

  • Verify device identifiers before use in any procedure.
  • Register recall alerts with Civco and your institution’s procurement team.
  • In future orders, confirm device-specific QA and inspection protocols during receipt.

Documentation advice

Keep the recall notice, document device identifiers (Part Number, UDI-DI, Lot Numbers), and recording of communications with Civco for records.

Product Details

Part Number: 667-159. UDI-DI: 00841436111102. Lot Numbers: A257459, A252198, A268105, A276632. Quantity: 21 units. Distribution: OH, PA, WA. Country of origin: China. Sold to healthcare providers in the United States. Recall Date: 2026-03-02. Status: ACTIVE. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 21 units recalled
  • Part Number 667-159
  • UDI-DI 00841436111102
  • Lot numbers A257459, A252198, A268105, A276632
  • Distribution in OH, PA, WA
  • China origin

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
UDI-DI: 00841436111102
A252198
A268105
A276632
Lot A257459
Affected States
OH, PA, WA
Report Date
April 8, 2026
Recall Status
ACTIVE

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