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
- eTRAX Needle Sensor 18G
- Model numbers
- UDI-DI: 00841436111102, A252198, A268105, A276632, Lot A257459
- 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 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
- Check Part Number 667-159 on your device.
- Verify UDI-DI 00841436111102 on the label.
- Confirm distribution states OH, PA, WA.
- 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.
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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
- Distribution in OH, PA, WA
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