FDA recall Z-1733-2026

Civco Medical Instruments Co. Inc. · Class II · device

Product

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

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.

Distribution

US States: OH, PA, WA. China.

Key facts

Status: Ongoing
Initiation date: 2026-03-02
Report date: 2026-04-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Kalona, IA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1733-2026