Data Foundry

Medical device recalls 2026

eTRAX Needle System Starter Kit 14G — Class II medical device recall Z-1732-2026

Ongoing recall by Civco Medical Instruments Co. Inc., reported 2026-04-08, distributed in OH, PA, WA. There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is

Recall numberZ-1732-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmCivco Medical Instruments Co. Inc., Kalona, IA, United States
Recall initiated2026-03-02
Classified2026-04-01
Reported by FDA2026-04-08
DistributedOH, PA, WA
Countries outside the USCN
Quantity6 units
UPC / GTIN / UDI-DI00841436111041
Lot numbersA228673
Model numbers667-150

Product

eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1732-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.