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Edge FileRecalls & reported problems across all models

US Endodontics, LLC · 48 models in the FDA device registry

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

1 open recall names at least one Edge File 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
1

We found 48 models of Edge File by US Endodontics, LLC in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

1 FDA recall record name at least one of these models by its device identifier, 1 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

Edge File 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. Jan 2, 2025Open, Classified

    Due to devices being irradiated above the established specification which my result in package integrity issues.

    Z-1114-2025 · Root cause: Under Investigation by firm · names 48 of these models · Recall details · FDA record ↗

Edge File models

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

Other US Endodontics, LLC products

All US Endodontics, LLC devices →

Sources and updates

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