Formula 0375554000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327061888), received between Feb 12, 2019 and Feb 19, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Overheating of Device

  IT WAS REPORTED THAT THE SHAVER BLADE STARTS TO BURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24396101 ↗
• MalfunctionDec 1, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A SMALL PIECE OF THE TEETH FROM THE SHAVER BLADE BROKE OFF IN MIDDLE OF CASE. THE PHYSICIAN CLEANED THE JOINT UP USING A NEW SHAVER BLADE AND THE SMALL METAL TOOTH WAS SUCTIONED UP USING ANOTHER SHAVER BLADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23688587 ↗
• MalfunctionJun 13, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533848 ↗
• MalfunctionMay 25, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17005183 ↗
• MalfunctionNov 11, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN STERILE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15782218 ↗
• MalfunctionFeb 12, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DISTAL TIP OF THE DEVICE BROKE OFF. THE BROKEN PIECE WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8331726 ↗