EdgeSequel SapphireRecalls & reported problems across all models
US Endodontics, LLC · 56 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one EdgeSequel Sapphire 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 56 models of EdgeSequel Sapphire 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
EdgeSequel Sapphire 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 56 of these models · Recall details · FDA record ↗
EdgeSequel Sapphire models
56 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EdgeSequel Sapphire SES150421FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES150425FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES150625FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES150631FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES200421FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES200425FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES200621FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES200625FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES200631FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES250421FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES250425FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES250621FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES250625FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES300421FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES300425FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES300621FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES300625FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES300631FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES350421FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES350425FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES350431FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES350621FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES350625FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES400421FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES400425FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES400625FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES400631FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES450421FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES450425FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES450431FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES450631FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES500421FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES500431FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES500625FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES550421FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES550425FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES600421FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES600425FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES600431FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES700421FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES700425FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES800425FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES900425FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SESSAST0421FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SESSAST0425FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SESSAST0431FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SESSAST0421LFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SESSAST0425LFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SESSAST0431LFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SESSAST0621FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SESSAST0625FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SESSAST0631FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SESSAST0631LFILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES250821FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES250825FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES250831FILE, 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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