The FDA announced on March 2, 2026, that Civco Medical Instruments Co. Inc. is recalling the eTRAX Needle System Starter Kit 18G due to a potential for incorrect needle tip position identification. The agency issued recall number Z-1734-2026 regarding the Class II device.
How to tell if you have it
- Brand: Civco Medical Instruments
- Product: eTRAX Needle System Starter Kit 18G (for Aurora Trackers)
- Part Number: 667-152
- Lot Numbers: A233347, A228677, A268116, A268238, A272513, A279457, A280388, A281840
- Distribution: OH, PA, WA, China
The hazard
According to the FDA, 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.
Context
GovInfoNow's records show Civco Medical Instruments Co. Inc. has 5 other recalls on record since 2018-02-23. Other recent recalls of similar products include GE Medical Systems Imactis CT-Navigation System Recall (2026-02-03), DeRoyal Myocardial Probe Recall (2026-08-20), and Canon Vantage Galan 3T Medical Device Recall (2025-10-16).