TI-MAX Z CONTRA/HP Z95LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04560264565951), received between Jul 10, 2025 and Jul 24, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Overheating of Device” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2025Overheating of Device; Overheating of Device

  ON JULY 3, 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 DENTIST WAS PERFORMING A DENTAL PROCEDURE ON A PATIENT USING THE Z95L HANDPIECE (SERIAL NO. (B)(6)). - DURING THE PROCEDURE, THE HEAD OF THE HANDPIECE MADE CONTACT WITH THE PATIENT'S LIP AS THE DENTIST WAS REMOVING IT FROM THEIR MOUTH, AND THE PATIENT RECEIVED A MINOR THERMAL BURN. - THE PATIENT CHECKED THE HANDPIECE AND FOUND THE HEAD HAD BECOME EXTREMELY HOT BUT WAS NOT AWARE THAT IT HAD HEATED UP. - THERE WAS NO VISIBLE BLISTERING TO THE PATIENT'S LIP, AND VASELINE WAS APPLIED TO THE AFFECTED AREA AT THE TIME OF THE INCIDENT. - THE PATIENT WAS REPORTED TO BE FINE THE NEXT DAY WITH NO DISCOMFORT.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 22584551 ↗
• InjuryJul 10, 2025Overheating of Device; Overheating of Device

  ON JUNE 17, 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 WAS PERFORMING A CROWN PREPARATION PROCEDURE ON A PATIENT USING THE Z95L HANDPIECE (SERIAL NO. (B)(6)). - DURING THE PROCEDURE, THE HANDPIECE OVERHEATED, AND THE PATIENT RECEIVED A MINOR THERMAL BURN INJURY TO THEIR LOWER LIP. - NO MEDICAL TREATMENT WAS NECESSARY AT THE TIME OF THE INJURY. - THE DENTIST HAD A FOLLOW-UP VISIT WITH THE PATIENT AND THE PATIENT IS REPORTED TO BE HEALING AS EXPECTED ALTHOUGH THE PATIENT DID MENTION FEELING SIGNIFICANT PAIN AROUND THE AFFECTED AREA.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 22465736 ↗
• InjuryJul 10, 2025Overheating of Device; Overheating of Device

  ON JUNE 17, 2025, NAKANISHI BECAME AWARE OF A HANDPIECE OVERHEATING THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (B)(4). DETAILS ARE AS FOLLOWS: - THE EVENT OCCURRED ON (B)(6) 2025. - THE DENTIST WAS PERFORMING A RESTORATIVE FILLING PROCEDURE ON TEETH NUMBERS 2, 3, 30, 31 OF A PATIENT USING THE Z95L HANDPIECE (SERIAL NO. (B)(6)) - DURING THE PROCEDURE, THE HANDPIECE OVERHEATED, AND THE PATIENT RECEIVED A SEVERE THERMAL BURN INJURY TO THEIR INNER LOWER LIP. - NO MEDICAL TREATMENT WAS NECESSARY AT THE TIME OF THE INJURY. - THE DENTIST HAD A FOLLOW-UP VISIT WITH THE PATIENT AND THE PATIENT IS REPORTED TO BE HEALING AS EXPECTED ALTHOUGH THE PATIENT DID MENTION FEELING NUMBNESS AROUND THE AFFECTED AREA.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 22465725 ↗