Aseptico AEU-25Recalls & reported problems
Aseptico, Inc. · Electronic Endodontic System · Class 1
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10817417020821), received between Jun 17, 2024 and Feb 18, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (6 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.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem6
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2026Mechanical Problem
IN THIS EVENT IT IS REPORTED THAT A MOTOR:ASEPTICO DTC STOPPED WORKING DURING USE WHILE IN PATIENT'S CANAL. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24380490 ↗MalfunctionAug 27, 2025Mechanical Problem; Mechanical Problem
IN THIS EVENT IT IS REPORTED THAT A ASEPTICO DTC MOTOR WAS RUNNING TOO FAST. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22903369 ↗MalfunctionAug 4, 2025Mechanical Problem; Mechanical Problem
IN THIS EVENT IT WAS REPORTED AN MOTOR: ASEPTICO DTC WAS RUNNING TO SLOW. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22703819 ↗MalfunctionSep 4, 2024Mechanical Problem; Mechanical Problem
IN THIS EVENT IT IS REPORTED THAT MOTOR: ASEPTICO DTC WAS AUTO REVERSING TOO QUICKLY. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20134156 ↗MalfunctionAug 26, 2024Mechanical Problem; Mechanical Problem
IN THIS EVENT IT IS REPORTED THAT MOTOR:ASEPTICO DTC WAS AUTO REVERSING TOO QUICKLY AND IS INCONSISTENT WITH ERROR MESSAGES. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20064916 ↗MalfunctionJun 17, 2024Mechanical Problem; Mechanical Problem
IN THIS EVENT IT IS REPORTED THAT PROMARK ENDO MOTOR - MOTOR:ASEPTICO DTC- WAS AUTO REVERSING TOO QUICKLY. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19547520 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.