EpilMe Applicator 300-1701Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850017374218), received between May 13, 2026 and May 13, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Misfire” (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.

• MalfunctionMay 13, 2026Misfire

  ACCORDING TO THE REPORT SUBMITTED BY THE DISTRIBUTOR, THE HAND PIECE STARTED FIRING BY ITSELF WHILE IN THE HOLDER AND THE TOUCH SCREEN DISPLAY WOULD NOT RESPOND TO TOUCH. THE SAPPHIRE TIP IS FROSTED OVER AND THE FRONT COVER IS MELTED. THE POWER METER INSIDE THE HAND PIECE HOLDER IS DAMAGED. ADVISED THE CLINIC TO NOT USE THE DEVICE AND RETURN FOR INVESTIGATION BY THE MANUFACTURER. THIS IS AN ISOLATED OCCURRENCE AND NO OTHER COMPLAINTS OF THIS NATURE HAVE BEEN REPORTED. NO INJURIES WERE ASSOCIATED WITH THIS EVENT. TECHNICAL INVESTIGATION DETERMINED THAT THE INCIDENT WAS CAUSED BY A MECHANICAL MALFUNCTION OF THE MICRO-SWITCH USED IN THE APPLICATOR TRIGGER ASSEMBLY. THE MICRO-SWITCH REMAINED IN AN ACTIVATED STATE AFTER THE OPERATOR RELEASED THE HAND TRIGGER, RESULTING IN CONTINUOUS TRIGGER SIGNAL DETECTION BY THE SYSTEM. AS A CONSEQUENCE, THE APPLICATOR CONTINUED EMITTING PULSES UNINTENTIONALLY WHILE POSITIONED IN THE DOCKING AREA. INSPECTION OF THE APPLICATOR INDICATED THAT THE MICRO-SWITCH IN THE TRIGGER MECHANISM HAD LIKELY BECOME MECHANICALLY BLOCKED OR FAILED INTERNALLY, PREVENTING PROPER RETURN OF THE MICRO-SWITCH TO ITS RELEASED POSITION. THE ISSUE WAS REPRODUCED DURING FUNCTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161793 ↗