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 14G
- Model numbers
- 667-150, 00841436111041, A228673
- 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 14G is used with Aurora Trackers for needle guidance in clinical settings. It is distributed to medical facilities and is part of Civco’s interventional tools.
Why This Is Dangerous
A sensor inspection and programming error can misidentify the needle tip position on the user interface, potentially affecting procedural accuracy and safety.
Industry Context
This recall is not presented as part of a broader industry pattern in the notice.
Real-World Impact
The immediate impact is restricted access to six units. Clinicians must suspend use and verify device identifiers before any further action.
Practical Guidance
How to identify if yours is affected
- 1. Locate Part Number 667-150 on the device or packaging.
- 3. Locate Lot Number A228673 on the label.
Where to find product info
Check the FDA recall page linked in the notice for official guidance and instructions.
What timeline to expect
Remedy/recall timeline not specified in the notice.
If the manufacturer is unresponsive
- Contact Civco Medical Instruments Co. Inc. for instructions.
- If Civco is unresponsive, consult your institution’s risk management office or the FDA.
- Document all communications and follow interim safety procedures.
How to prevent similar issues
- Verify device identifiers before use in any procedure.
- Establish a recall-check protocol for all Civco devices in use.
- Monitor for updates from FDA and Civco.
Documentation advice
Keep packaging, serial numbers, recall notification, and all communications for audit and potential insurance purposes.
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Product Details
Model numbers: Part Number 667-150. UDI-DI 00841436111041. Lot Number A228673. Sold to healthcare facilities in OH, PA and WA. Quantity recalled: 6 units. Country of origin: China. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Lot Number A228673
- Distributed to OH, PA, WA (USA) and China
- Hazard: incorrect needle tip identification on UI
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Safety Guide
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