Quick Facts at a Glance
- Recall Date
- March 2, 2026
- Hazard Level
- HIGH
- Brand
- Civco Medical Instruments
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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
- Product type
- Needle System Starter Kit
- Model numbers
- 667-149, 00841436111034, A228672
- Sold at
- Multiple Retailers
- 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 System Starter Kit 12G is used with Aurora Trackers in procedures requiring precise needle guidance. The kit is designed for clinicians in specialty settings.
Why This Is Dangerous
A sensor error can cause incorrect needle tip position readings on the user interface, potentially affecting procedural accuracy and patient safety.
Industry Context
This recall is not presented as part of a broader industry pattern in the notice.
Real-World Impact
Clinicians may rely on needle tip position data displayed by the interface. Misidentification could lead to inaccurate needle placement or additional procedural risk.
Practical Guidance
How to identify if yours is affected
- Check if you own Part Number 667-149 eTRAX Needle System Starter Kit 12G for Aurora Trackers.
- Verify UDI-DI 00841436111034 and Lot Number A228672 on the device label.
- Confirm distribution was to OH, PA, WA or China.
Where to find product info
Identifiers appear on the device label and packaging. The FDA recall page lists the official recall details.
What timeline to expect
Remedies are under manufacturer guidance. Process timelines often range from 4-6 weeks for refunds or replacements.
If the manufacturer is unresponsive
- Escalate with the hospital or purchasing organization.
- Document all correspondence and request escalation to Civco corporate support.
How to prevent similar issues
- Verify device recalls before procurement.
- Register and track recall notices from the FDA and manufacturer websites.
- Work with procurement to ensure rapid follow-up on recalls.
Documentation advice
Keep recall notice, device labels showing Part Number 667-149, UDI-DI 00841436111034, Lot A228672, and all correspondence with Civco for records.
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Product Details
Part Number: 667-149. UDI-DI: 00841436111034. Lot Number: A228672. Quantity recalled: 2 units. Sold to healthcare providers in OH, PA, WA and China. Recall date: 2026-03-02. Status: ACTIVE.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distributed to OH, PA, WA and China
- No injuries reported so far
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Safety Guide
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