Civco Medical Instruments Co. Inc.: System, Imaging, Pulsed Echo, Ultrasonic
Recall Summary Civco Medical Instruments is recalling the eTRAX Needle System Starter Kit 16G for Aurora Trackers due to a manufacturing error that may cause the needle tip position to display incorrectly on the screen. The product was distributed in Ohio, Pennsylvania, Washington, and China. This is a Class II recall, meaning there is potential for serious adverse health consequences.
- Recalling firm
- Civco Medical Instruments Co. Inc.
- Product
- 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.
- 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/1d7a1b9f-7a91-4f6c-9c83-996ceb780425