EdgeTaper PlatinumRecalls & reported problems across all models
US Endodontics, LLC · 25 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one EdgeTaper Platinum 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 25 models of EdgeTaper Platinum 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
EdgeTaper Platinum 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 25 of these models · Recall details · FDA record ↗
EdgeTaper Platinum models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EdgeTaper Platinum SETSX19HTFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETS121HTFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETS125HTFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETS131HTFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETS221HTFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETS225HTFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETS231HTFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETF121HTFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETF125HTFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETF131HTFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETF221HTFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETF225HTFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETF231HTFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETF321HTFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETF325HTFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETF331HTFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETF421HTFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETF425HTFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETF431HTFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETF521HTFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETF525HTFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETF531HTFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETP21MMFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETP25MMFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper Platinum SETP31MMFILE, 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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