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U.S. Department of Health and Human Services

Class 2 Device Recall eTRAX Needle Sensor 12G

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 Class 2 Device Recall eTRAX Needle Sensor 12Gsee related information
Date Initiated by FirmMarch 02, 2026
Date PostedApril 01, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1735-2026
Recall Event ID 98513
510(K)NumberK092619 
Product Classification System, imaging, pulsed echo, ultrasonic - Product Code IYO
ProducteTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
Code Information UDI-DI: 00841436111072; Lot Number: A276634
FEI Number 1937223
Recalling Firm/
Manufacturer		 Civco Medical Instruments Co. Inc.
102 1st St S
Kalona IA 52247-9589
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Software change control
ActionAn URGENT: MEDICAL DEVICE RECALL notification letter dated 3/2/26 was sent to customers. Actions to be taken by the Customer/User: CIVCO requests that you check your inventory for any eTRAX Needle Sensor for Aurora Trackers and complete the supplied response letter for the appropriate action. Please contact your distribution partner to return any existing inventory, or report its destruction by completing the attached response form. Please complete the enclosed response form even if you do not have any eTRAX Needle Sensor for Aurora Trackers remaining in your inventory to assist in our reconciliation process. Response forms can also be sent via email to distorder@civco.com. For questions, contact CIVCO at # 800-445-6741, or 319-248-6757. Type of Action by the Company: This notice is being communicated to all customers who have purchased an eTRAX Needle Sensor for Aurora Trackers from affected lots. CIVCO requests you provide this notification to the appropriate personnel within your facility. If the affected product was distributed outside of your organization, please notify those locations down to the medical facility level.
Quantity in Commerce5 units
DistributionUS States: OH, PA, WA. China.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = IYO
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