Ti-Max X X-SG65LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04560264518575), received between Oct 27, 2025 and Oct 27, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Overheating of Device” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2025Overheating of Device; Overheating of Device

  ON OCTOBER 28, NAKANISHI RECEIVED FURTHER INFORMATION ON THE EVENT FROM THE DISTRIBUTOR. - AT THE TIME OF THE EVENT, THE DENTIST WAS PERFORMING A REMOVAL PROCEDURE OF #18, 28, 38 AND 48 WISDOM TEETH. - THE DENTIST OBSERVED SLIGHTLY NOISY DRILL SOUND FROM THE HANDPIECE DURING ROTATION PRIOR TO THE INCIDENT. - DURING THE PROCEDURE, THE HANDPIECE OVERHEATED FROM ONLY 10 SECONDS OF USE, AND THE PATIENT RECEIVED A MINOR BURN TO THE PATIENT'S LOWER LEFT LIP. - THE PATIENT IS EXPECTED TO BE HEALED NORMALLY WITHOUT NEED FOR ANY FURTHER MEDICAL TREATMENT. - ACCORDING TO THE DENTIST, THERE WERE NO ABNORMALITIES OBSERVED IN THE DEVICE PRIOR TO USE.

  Patient problems: Burn(s)

  MAUDE report 23399087 ↗