Formula 0375708500Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327057645), received between Aug 25, 2020 and Dec 4, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Continuous Firing” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE FORMULA 180 SHAVER HAND PIECE WAS GETTING REALLY HOT AND BURNT THE PATIENTS SKIN. IT WAS A LITTLE BURN THAT DID NOT REQUIRE ANY MEDICAL INTERVENTION.

  Patient problems: Burn(s)

  MAUDE report 23719537 ↗
• MalfunctionNov 22, 2022Continuous Firing; Continuous Firing

  IT WAS REPORTED THAT THE DEVICE WAS CONTINUOUSLY ACTIVATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15848536 ↗
• MalfunctionOct 10, 2022Continuous Firing; Continuous Firing

  IT WAS REPORTED THAT THE DEVICE WAS CONTINUOUSLY ACTIVATING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15573532 ↗
• InjurySep 28, 2022Insufficient Cooling; Insufficient Cooling; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BURNED.

  Patient problems: Burn(s)

  MAUDE report 15496838 ↗
• MalfunctionNov 19, 2021Mechanical Problem; Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE PROCEDURE NEEDED TO BE RESCHEDULED DUE TO THE DEVICE NOT WORKING AND NOT HAVING A REPLACEMENT. THE PATIENT WAS UNDER ANESTHESIA, BUT NO INCISIONS WERE MADE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12845052 ↗
• MalfunctionAug 10, 2021Melted; Adverse Event Without Identified Device or Use Problem; Melted

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Superficial (First Degree) Burn

  MAUDE report 12304967 ↗
• MalfunctionAug 3, 2021Smoking; Smoking

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT. NOTE, IT WAS NOTICED DURING INSPECTION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12270888 ↗
• MalfunctionAug 25, 2020Smoking; Smoking

  IT WAS REPORTED THERE WAS A THERMAL EVENT. PLEASE NOTE THIS WAS NOTICED DURING INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10451179 ↗