Civco Medical Instruments Co. Inc.: System, Imaging, Pulsed Echo, Ultrasonic
Recall Summary Civco Medical Instruments is recalling the eTRAX Needle System Starter Kit 14G for Aurora Trackers due to an inspection and programming error that could cause the needle tip position to display incorrectly on the screen. The affected product was distributed in Ohio, Pennsylvania, and Washington, as well as China. This is a Class II recall.
- Recalling firm
- Civco Medical Instruments Co. Inc.
- Product
- eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-02
- Status
- Open, Classified
- Areas affected
- OH, PA, WA
- Distribution
- US States: OH, PA, WA. China.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/4b34b936-e350-425c-80e5-7e7586da6495