EdgeOne FireRecalls & reported problems across all models
US Endodontics, LLC · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one EdgeOne Fire 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 15 models of EdgeOne Fire 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
EdgeOne Fire 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.
- 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 15 of these models · Recall details · FDA record ↗
EdgeOne Fire models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EdgeOne Fire SEOFSM21FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeOne Fire SEOFSM25FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeOne Fire SEOFSM31FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeOne Fire SEOFPRI21FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeOne Fire SEOFPRI25FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeOne Fire SEOFPRI31FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeOne Fire SEOFMED21FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeOne Fire SEOFMED25FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeOne Fire SEOFMED31FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeOne Fire SEOFLG21FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeOne Fire SEOFLG25FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeOne Fire SEOFLG31FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeOne Fire SEOFAST21FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeOne Fire SEOFAST25FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeOne Fire SEOFAST31FILE, PULP CANAL, ENDODONTIC1 recall0 reports
Other US Endodontics, LLC products
All US Endodontics, LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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