FDA Device recall Z-1734-2026
eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
- FDA Device
- Class II
- ongoing
- Published 2026-04-08
On 2026-04-08 the FDA classified a Class II recall of eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152 by Civco Medical Instruments, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1734-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-02 |
| Published | 2026-04-08 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Civco Medical Instruments |
| Distribution | OH, PA, WA |
Product
eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
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.
Identifiers
| code_info | UDI-DI: 00841436111065; Lot Number: A233347, A228677, A268116, A268238, A272513, A279457, A280388 , A281840 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1734-2026%22
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