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eTRAX Needle System Starter KitRecalls & reported problems across all models

Civco Medical Instruments CO., Inc. · 4 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

4 open recalls name at least one eTRAX Needle System Starter Kit model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls
4

We found 4 models of eTRAX Needle System Starter Kit by Civco Medical Instruments CO., Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

4 FDA recall records name at least one of these models by its device identifier, 4 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

eTRAX Needle System Starter Kit recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. Mar 2, 2026Open, Classified

    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.

    Z-1734-2026 · Root cause: Software change control · Recall details · FDA record ↗

  2. Mar 2, 2026Open, Classified

    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.

    Z-1733-2026 · Root cause: Software change control · Recall details · FDA record ↗

  3. Mar 2, 2026Open, Classified

    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.

    Z-1732-2026 · Root cause: Software change control · Recall details · FDA record ↗

  4. Mar 2, 2026Open, Classified

    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.

    Z-1731-2026 · Root cause: Software change control · Recall details · FDA record ↗

eTRAX Needle System Starter Kit models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

Other Civco Medical Instruments CO., Inc. products

All Civco Medical Instruments CO., Inc. devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page