TI-MAX nano CONTRA/HP nano95LSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04560264566002), received between Sep 11, 2025 and Sep 12, 2025 — 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2025Overheating of Device; Overheating of Device

  ON AUGUST 19, 2025, NAKANISHI BECAME AWARE OF A HANDPIECE OVERHEATING THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (NSK AMERICA). DETAILS ARE AS FOLLOWS: - THE EVENT OCCURRED ON (B)(6) 2025. - THE DENTIST RAN THE NANO95LS HANDPIECE (SERIAL NO. (B)(6)) OUTSIDE OF THE PATIENT'S MOUTH TO MAKE SURE WATER AND LIGHT COMES ON. - WITHIN A FEW SECONDS OF WORKING ON THE TOOTH THE PATIENT REACTED IN PAIN. - THE DENTIST ASKED THE PATIENT IF THE TOOTH WAS NUMB AND THEY STATED IT WAS FINE, SO THE DENTIST PROCEEDED WITH THE PREPARATION OF THE TOOTH FOR THE CROWN. - ONCE THE DENTIST REMOVED THE HANDPIECE FROM THE PATIENT'S MOUTH TO CHANGE BURS, THE DENTIST NOTICED THAT THE HEAD OF THE HANDPIECE WAS EXTREMELY HOT TO THE TOUCH. - THIS IS WHEN THE DENTIST OBSERVED THAT THE PATIENT'S BUCCAL MUCOSA HAD BEEN BURNED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 23034849 ↗
• InjurySep 11, 2025Overheating of Device; Overheating of Device

  THE DOCTOR REPORTED THAT THEY RAN THE HANDPIECE OUTSIDE OF THE PATIENT'S MOUTH TO MAKE SURE WATER AND LIGHT COMES ON. WITHIN A FEW SECONDS OF WORKING ON THE TOOTH THE PATIENT REACTED IN PAIN. THE DOCTOR ASKED THE PATIENT IF THE TOOTH WAS NUMB AND THEY STATED IT WAS FINE, SO THE DOCTOR PROCEEDED WITH THE PREPARATION OF THE TOOTH FOR THE CROWN. ONCE THE DOCTOR REMOVED THE HANDPIECE FROM THE PATIENT'S MOUTH TO CHANGE BURS, THE DOCTOR NOTICED THE HEAD OF THE HANDPIECE WAS EXTREMELY HOT TO THE TOUCH. THIS IS WHEN THE DOCTOR OBSERVED THAT THE PATIENT'S BUCCAL MUCOSA HAD BEEN BURNED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 23032289 ↗