Z99LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04589551391585), received between May 7, 2026 and Sep 30, 2026 — 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. How this data works · Data updated Oct 13, 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.

• InjurySep 30, 2026Overheating of Device

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 50952771 ↗
• InjuryMay 13, 2026Overheating of Device

  ON APRIL 25, 2026, NAKANISHI BECAME AWARE OF HANDPIECE OVERHEATING THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (NSK AMERICA). DETAILS ARE AS FOLLOWS: - THE EVENT OCCURRED ON APRIL 8, 2026. - THE DENTIST WAS PERFORMING A CROWN PREPARATION PROCEDURE ON A PATIENT USING THE Z99L HANDPIECE (SERIAL NO. (B)(6)). - DURING THE PROCEDURE, THE HANDPIECE BACK-CAP OVERHEATED ABNORMALLY, AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THE INSIDE OF THEIR CHEEK. - THE DENTIST REPORTED THE FOLLOWING "I WAS FINALIZING MY PREPARATION OF BOTH #29 AND #30, SO AT THAT TIME WE TOOK OUT THE CHEEK RETRACTOR I HAD BEEN USING THROUGHOUT THE PROCEDURE SO THE PATIENT COULD BITE, AND I COULD VERIFY MY OCCLUSAL REDUCTION WAS ADEQUATE. AFTER REALIZING I NEEDED A MINOR AMOUNT OF EXTRA REDUCTION, I TILTED MY HANDPIECE TO BE PARALLEL TO THE OCCLUSAL TABLE TO DO THE FINAL ADJUSTMENT, LEADING TO THE BACK OF THE HANDPIECE (WHERE I'D PUSH TO EJECT A BUR) RESTING ON THE PATIENT'S CHEEK. DURING THIS LAST STEP, THE PATIENT ABRUPTLY RAISED HER HAND AND INDICATED IT WAS HOT. I TOUCHED THE BACK OF THE HANDPIECE, AND IT WAS EXTREMELY HOT AND CHARRED LOOKING (BLACKENED). AT THIS POINT I SAW A SIGNI

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 25156905 ↗
• InjuryMay 7, 2026Overheating of Device

  DURING A CROWN PREPARATION PROCEDURE, THE HANDPIECE BACK-CAP OVERHEATED ABNORMALLY, AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THE INSIDE OF THEIR CHEEK. THE DOCTOR REPORTED THE FOLLOWING "I WAS FINALIZING MY PREPARATION OF BOTH #29 AND #30, SO AT THAT TIME WE TOOK OUT THE CHEEK RETRACTOR I HAD BEEN USING THROUGHOUT THE PROCEDURE SO THE PATIENT COULD BITE, AND I COULD VERIFY MY OCCLUSAL REDUCTION WAS ADEQUATE. AFTER REALIZING I NEEDED A MINOR AMOUNT OF EXTRA REDUCTION, I TILTED MY HANDPIECE TO BE PARALLEL TO THE OCCLUSAL TABLE TO DO THE FINAL ADJUSTMENT, LEADING TO THE BACK OF THE HANDPIECE (WHERE I'D PUSH TO EJECT A BUR) RESTING ON THE PATIENT'S CHEEK. DURING THIS LAST STEP, THE PATIENT ABRUPTLY ROSE HER HAND AND INDICATED IT WAS HOT. I TOUCHED THE BACK OF THE HANDPIECE, AND IT WAS EXTREMELY HOT AND CHARRED LOOKING (BLACKENED). AT THIS POINT I SAW A SIGNIFICANT BURN ON THE PATIENT'S CHEEK. I RE-ANESTHETIZED FOR COMFORT SO WE COULD SCAN THE TEETH AND FABRICATED TEMPS. I INFORMED THE PATIENT OF WHAT HAPPENED." THE PATIENT WAS PRESCRIBED PAIN MEDICATION AND AN ORAL RINSE AT THE TIME OF THE INCIDENT. THE PATIENT REPORTED TO THE DOCTOR THAT THEY WERE IN SO MUCH PAIN AFTER THE LO

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 25117505 ↗