Civco Medical Instruments Co. Inc. recalls eTRAX Needle System Starter Kit 16G(for Aurora Trackers)

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.

eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151

An 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.

• FDA enforcement recordOfficial FDA database entry for Z-1733-2026
• FDA 510(k) clearance · K092619The device's official FDA premarket clearance record
• FDA device classification · IYOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1560The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Civco Medical Instruments Co. Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.