TI-MAX X CONTRA/HP X95LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04560264565845), received between Jun 12, 2026 and Jun 12, 2026 — 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.

• InjuryJun 12, 2026Overheating of Device

  DURING A CROWN PREPARATION ON TOOTH #18 THE HEAD OF THE HANDPIECE BECAME VERY HOT RESULTING IN A THERMAL BURN INJURY TO THE RIGHT SIDE OF THE PATIENT'S TONGUE. THERE HAS NOT BEEN ANY FOLLOW-UP WITH THE PATIENT SINCE THE INCIDENT, AND IT IS UNKNOWN IF THERE WAS NEED FOR ADDITIONAL MEDICAL TREATMENT BECAUSE OF THE INJURY. THE PATIENT HAS BEEN UNRESPONSIVE TO ANY OF PRACTICES ATTEMPTS FOR A FOLLOW-UP EXAMINATION OR OBTAINING INFORMATION ON THE STATUS OF THEIR INJURY. THE DENTAL PRACTICE IS UNSURE OF WHICH HANDPIECE WAS INVOLVED IN THE INCIDENT OUT OF THE TWO HANDPIECES THEY HAVE IDENTIFIED AS SUSPECT DEVICES. BOTH DEVICES ARE BEING REPORTED SEPARATELY FOR THE SAME ADVERSE EVENT. THIS IS REPORT 1 OF 2. [REFERENCE MDR 2026-00021 FOR THE SECOND SUSPECT DEVICE INFORMATION].

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 25490890 ↗