SGA-E2SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04560225001214), received between Jan 19, 2026 and Jan 19, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Overheating of Device” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 2026Overheating of Device

  ON DECEMBER 22, 2025, NAKANISHI BECAME AWARE OF A HANDPIECE OVERHEATING THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (B)(4). THE DETAILS ARE AS FOLLOWS: THE EVENT OCCURRED ON DECEMBER 1, 2025. THE DENTIST WAS PERFORMING A DENTAL PROCEDURE ON A PATIENT USING THE SGA-E2S HANDPIECE (SERIAL NO. (B)(6). DURING THE PROCEDURE, THE HANDPIECE OVERHEATED, AND THE PATIENT RECEIVED A BURN INJURY.

  Patient problems: Burn(s)

  MAUDE report 24112018 ↗
• InjuryJan 19, 2026Overheating of Device

  ON DECEMBER 22, 2025, NAKANISHI BECAME AWARE OF A HANDPIECE OVERHEATING THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (B)(4) . THE DETAILS ARE AS FOLLOWS: THE EVENT OCCURRED ON DECEMBER 1, 2025. THE DENTIST WAS PERFORMING A DENTAL PROCEDURE ON A PATIENT USING THE SGA-E2S HANDPIECE (SERIAL NO. (B)(6). DURING THE PROCEDURE, THE HANDPIECE OVERHEATED, AND THE PATIENT RECEIVED A BURN INJURY.

  Patient problems: Burn(s)

  MAUDE report 24111999 ↗