Z-1733-2026Class II

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

Name: Z-1733-2026 eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
Creator: Civco Medical Instruments Co. Inc.
Published: 2026-03-02
License: https://open.fda.gov/license/

CIVCO Medical Instruments Co., Inc. / initiated 2026-03-02 / Open, Classified / root cause: software

FDA source

Civco Medical Instruments Co. Inc. began a recall of eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151 on 2026-03-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1733-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-02
Posted: 2026-04-01
Recalling firm: CIVCO Medical Instruments Co., Inc.
Product: eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
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.
Root cause tag: software
FDA root cause: Software change control
Action: 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 [email protected]. 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 commerce: 18 units
Distribution: US States: OH, PA, WA. China.
Product codes and lots: UDI-DI: 00841436111058; Lot Number: A228675, A228676, A233854, A268115, A268237, A272509, A277538, A280341

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1733-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1731-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-01
Z-1732-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-01
Z-1733-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-01
Z-1734-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-01
Z-1735-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-01
Z-1736-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-01
Z-1737-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-01
Z-1738-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-01

Product code IYO

K092619Class IIEtrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal TrackerCivco / cleared 2009-11-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)