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
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 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.
Recall announced
March 2, 2026
Reported by FDA DEVICE
April 8, 2026
RecallRadar source check
April 15, 2026
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
- Check Part Number 667-157 on the device.
- Verify UDI-DI 00841436111089 and Lot A276633.
- 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
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