Gutta-Percha
FDA adverse event reports and recall history for gutta-percha (product code EKM), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 128
- Deaths
- 0
- Injuries
- 106
- Malfunctions
- 21
Reports per year
Source: FDA adverse event reports by year received, 2006–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2011-11-04TerminatedError in labeling
Microseal Master Cone Part Number: 815-9033 Microseal Master Cone is intended to obturate root canals during endodontic therapy procedures.
The recall was initiated because SybronEndo has confirmed that the Microseal Master Cones has been mislabeled.
- 2009-12-09TerminatedComponent design/selection
Elements Gutta Percha and Elements RealSeal Cartridges; Part Number: 972-1002, 972-1003, 972-2001, 972-2002
The recall was initiated because during the manufacturing process of the affected units, the molding process resulted in lock nuts that did not have the level of acceptability required, and therefore, may not withstand the pressures exhibited by the Elements Obturation Unit with which the cartridges are used. More Specifically, there exists a possibility that if the lock nut were to fail, the cart
- TerminatedError in labeling
TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment
Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50pk because the inner generic label is identified as ML3. The products outer package is identified as SM3 which matches the product inside.
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