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

FDA device recall Z-1733-2026 · posted 2026-04-01 · Open, Classified

Recall details

Recalling firm

Civco Medical Instruments Co. Inc.

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.

Action taken

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.

Root cause

Software change control

Status

Open, Classified

Product code

IYO

Quantity affected

18 units

Distribution

US States: OH, PA, WA. China.

Date initiated

2026-03-02

Date posted

2026-04-01

Location

Kalona, IA

Related 510(k) clearances