Z890LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04589551385348), received between Jun 21, 2024 and Dec 11, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Overheating of Device” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2025Overheating of Device; Overheating of Device

  ON (B)(6) 2025, NAKANISHI BECAME AWARE OF A HANDPIECE OVERHEATING THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (NSK AMERICA). ACCORDING TO THE DISTRIBUTOR, TWO PATIENTS WERE INVOLVED WITH THE DEVICE. THEREFORE, NAKANISHI IS SUBMITTING TWO MDRS FOR THE TWO PATIENTS. THE DETAILS NAKANISHI OBTAINED ABOUT THE SECOND PATIENT ARE AS FOLLOWS. - THE DENTIST WAS PERFORMING A DENTAL PROCEDURE ON A PATIENT USING THE Z890L HANDPIECE (SERIAL NO. (B)(6). - DURING THE PROCEDURE, THE BACK OF THE HANDPIECE HEAD OVERHEATED, AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR INNER CHEEK.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 23785511 ↗
• InjuryDec 11, 2025Overheating of Device; Overheating of Device

  ON (B)(6) , 2025, NAKANISHI BECAME AWARE OF A HANDPIECE OVERHEATING THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (NSK AMERICA). ACCORDING TO THE DISTRIBUTOR, TWO PATIENTS WERE INVOLVED WITH THE DEVICE. THEREFORE, NAKANISHI IS SUBMITTING TWO MDRS FOR THE TWO PATIENTS. THE DETAILS NAKANISHI OBTAINED ABOUT THE FIRST PATIENT ARE AS FOLLOWS. - THE DENTIST WAS PERFORMING A DENTAL PROCEDURE ON A PATIENT USING THE Z890L HANDPIECE (SERIAL NO. (B)(6) ) - DURING THE PROCEDURE, THE BACK OF THE HANDPIECE HEAD OVERHEATED, AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR INNER CHEEK.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 23785469 ↗
• InjuryNov 21, 2025Overheating of Device; Overheating of Device

  DENTAL OFFICE REPORTED THAT THEIR PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR INNER CHEEK FROM THE BACK OF THE HANDPIECE HEAD DURING A PROCEDURE. PATIENT INFORMATION AND DATE OF THE ADVERSE EVENT HAVE NOT BEEN PROVIDED BY THE DENTAL PRACTICE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF THIS INFORMATION IS MADE AVAILABLE BY THE DENTAL OFFICE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 23623586 ↗
• InjuryNov 21, 2025Overheating of Device; Overheating of Device

  DENTAL OFFICE REPORTED THAT THEIR PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR INNER CHEEK FROM THE BACK OF THE HANDPIECE HEAD DURING A PROCEDURE. PATIENT INFORMATION AND DATE OF THE ADVERSE EVENT HAVE NOT BEEN PROVIDED BY THE DENTAL PRACTICE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF THIS INFORMATION IS MADE AVAILABLE BY THE DENTAL OFFICE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 23623535 ↗
• InjuryJun 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DOCTOR WAS PERFORMING A CROWN PREPARATION WHEN HE NOTICED THAT THE HANDPIECE BEGAN TO LOSE POWER AND WAS NOT CUTTING WELL, IT THEN BECAME NOTICEABLY LOUDER AND THE BUR ALONG WITH THE INTERNAL PARTS JUST SHOT OUT INTO THE PATIENT'S MOUTH. THE DOCTOR WAS ABLE TO QUICKLY RETRIEVE THE PARTS AND THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19580550 ↗