Midas Rex® EF200RF (UDI 00613994614612)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994614612), received between Mar 28, 2025 and Mar 28, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Self-Activation or Keying” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT INTRA-OP, IPC FOOTSWITCH WAS NOT TURNING THE DRILL. THE FOOT SWITCH WAS SELF ACTIVATING. FOOT SWITCH WAS CHANGED AND THE PROBLEM WENT AWAY. THE HAND PIECE WAS WORKING CORRECTLY AFTER THE FOOTSWITCH WAS CHANGED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21716222 ↗