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 18G
- Model numbers
- UDI-DI: 00841436111065, Lot Number: A233347, A228677, A268116, A268238, A272513, A279457, A280388 +1 more
- 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 18G is used with Aurora Trackers for needle-based procedures. It is a Class II medical device in the recall.
Why This Is Dangerous
An error in inspection and programming of the needle sensor may cause the needle tip position to be misidentified on the user interface, potentially affecting procedure accuracy.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
20 units across OH, PA, WA and China are affected. Immediate stop-use is required. Providers should follow recall instructions to determine replacement or refund actions.
Practical Guidance
How to identify if yours is affected
- Check Part Number 667-152 on the kit.
- If your kit matches any identifiers, stop use and follow manufacturer instructions.
Where to find product info
Identify labels on the device and packaging for UDI-DI and lot numbers.
What timeline to expect
No processing timeline is provided in the recall notice.
If the manufacturer is unresponsive
- Document all communications with Civco and healthcare providers.
- File a complaint with the FDA if you believe safety is at risk and the company is not responding.
How to prevent similar issues
- Verify identifiers before use in any needle system kit.
- Follow manufacturer recall communications for remediation.
- Keep all packaging and documentation for future reference.
- Check regulator recall databases for updates on replacements or refunds.
Documentation advice
Save recall notice, packaging, serial/lot numbers, photos of labels, and all correspondence with Civco or providers.
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Product Details
Model numbers and identifiers include UDI-DI 00841436111065; Lot numbers A233347, A228677, A268116, A268238, A272513, A279457, A280388, A281840. Part Number 667-152. Distribution: Ohio, Pennsylvania, and Washington in the United States, plus China. Quantity: 20 units.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Quantity recalled: 20 units
- Distribution: OH, PA, WA, and China
- Hazard: Needle tip misidentification on user interface
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Safety Guide
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