eTRAX Needle System Starter Kit 16G recall (Civco Medical Instruments Co. Inc.)
Medical deviceClass IIOngoing
Summary: Civco Medical Instruments Co. Inc. is recalling eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151. Reason: 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 is being recalled
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US States: OH, PA, WA. China. (states named: Ohio, Pennsylvania, Washington)
How to tell if yours is affected
UDI-DI: 00841436111058; Lot Number: A228675, A228676, A233854, A268115, A268237, A272509, A277538, A280341
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1733-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 2, 2026 |
| Reported | April 8, 2026 |
| Company | Civco Medical Instruments Co. Inc. |
| Company location | Kalona, IA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 18 units |
More recalls from Civco Medical Instruments Co. Inc. · all medical device recalls · recalls from March 2026