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 System Starter Kit 16G for Aurora Trackers
- Model numbers
- UDI-DI: 00841436111058, Lot Number: A228675, A228676, A233854, A268115, A268237, A272509, A277538 +1 more
- 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 System Starter Kit is a medical device used with Aurora Trackers for needle guidance during procedures.
Why This Is Dangerous
An error in inspection and programming of the needle sensor can cause the needle tip position to be misidentified on the user interface, potentially affecting accuracy during procedures.
Industry Context
This recall is not stated as part of a broader industry pattern in the notice.
Real-World Impact
Immediate cessation of use is required. The impact is procedural disruption and potential patient safety risk if the device is used.
Practical Guidance
How to identify if yours is affected
- Check the Part Number 667-151 and UDI-DI 00841436111058 on the device label.
- Review the Lot Numbers list to determine if your unit is affected.
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Where to find product info
Find UDI-DI on the device label or packaging. Lot numbers are printed on the product packaging or label.
What timeline to expect
Refunds or replacements are determined by Civco and may take weeks. Expect 4-6 weeks for processing.
If the manufacturer is unresponsive
- Document all contact attempts with Civco and the FDA; escalate to consumer protection if the company is unresponsive.
- Consider contacting your hospital risk management department for guidance.
How to prevent similar issues
- Verify supplier and product status before procurement; require updated serial numbers and batch information; monitor for recall updates from the FDA.
- Avoid purchasing recalled lots or substitutes without official verification.
Documentation advice
Keep photos of the label, UDI-DI, lot numbers, and recall notices. Save email threads and recall notices.
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Product Details
Model numbers and lot numbers: UDI-DI 00841436111058; Lot Numbers A228675, A228676, A233854, A268115, A268237, A272509, A277538, A280341. Part Number 667-151. Quantity: 18 units. Distribution: OH, PA, WA in the United States and China. Manufacturer: Civco Medical Instruments Co.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distribution in OH, PA, WA and China
- Recall date 2026-03-02; status ACTIVE
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Safety Guide
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