HIGHFDA DEVICE

Civco Medical eTRAX 14G Needle Sensor Recall for 5 Units (2026)

Civco Medical Instruments Co. is recalling 5 eTRAX Needle Sensor 14G units for Aurora Trackers. The recall cites a programming and inspection error that could cause the needle tip position to be misidentified on the user interface. Stop using the device immediately and contact Civco for instructions.

Official notice
Civco Medical Instruments Co.Health & Personal CareMedical DevicesUDI-DI: 00841436111089Lot Number: A276633Part Number: 667-157

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
March 2, 2026
Status
ACTIVE
Severity
7/10

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Civco Medical Instruments Co.
Product type
Needle Sensor
Model numbers
UDI-DI: 00841436111089, Lot Number: A276633, Part Number: 667-157
Sizes
Unknown
Sold at
Unknown
Where affected
OH, PA, WA

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    March 2, 2026

  2. Reported by FDA DEVICE

    April 8, 2026

  3. RecallRadar source check

    April 15, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

About This Product

The eTRAX needle sensor is used with Aurora Trackers to identify needle tip position during procedures. This recall involves a specific 14G sensor unit produced under Part 667-157.

Why This Is Dangerous

A software/inspection error can cause the needle tip position to be misidentified on the user interface, which could lead to incorrect needle placement decisions.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Clinicians may need to halt procedures using the affected sensor until replacement or instructions are provided; the recall is limited to 5 units.

Practical Guidance

How to identify if yours is affected

  1. Check Part Number 667-157 on the device.
  2. Verify UDI-DI 00841436111089 and Lot A276633.
  3. Confirm distribution states OH, PA, WA and China.

Where to find product info

Recall details available at the FDA enforcement page and Civco notice linked in the recall.

What timeline to expect

Remedies will be provided by Civco; typical replacement or remedy timeline is determined by the manufacturer and clinical settings.

If the manufacturer is unresponsive

  • Escalate to hospital compliance or infection control leadership.
  • Document all contact attempts with the manufacturer and FDA.
  • File any consumer complaints with the FDA if needed.

How to prevent similar issues

  • Verify device recall status before use in any procedure.
  • Cross-check UDI-DI and lot numbers for every sensor.
  • Establish inventory controls to isolate recalled units.
  • Stay updated via FDA recall notices and manufacturer communications.

Documentation advice

Keep the recall notice, device identifiers (Part 667-157, UDI-DI 00841436111089, Lot A276633), purchase records, and any correspondence with Civco or medical facilities.

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Product Details

Model: Part Number 667-157. UDI-DI: 00841436111089. Lot Number: A276633. Distribution: OH, PA, WA; China. Recall Date: 2026-03-02. Status: Active. Manufacturer: Civco Medical Instruments Co. Inc.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • Distributed in OH, PA, WA and China
  • FDA enforcement recall: Z-1736-2026

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
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
UDI-DI: 00841436111089
Lot Number: A276633
Part Number: 667-157
Affected States
OH, PA, WA
Report Date
April 8, 2026
Recall Status
ACTIVE

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