Accu-Temp® 8442000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30886158010266), received between Apr 28, 2023 and Oct 17, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fire” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2024Sparking; Sparking

  ON SEPTEMBER 26TH, 2024 BVI HAS BEEN NOTIFIED BY FDA ABOUT MEDICAL DEVICE REPORT RECEIVED VIA THE MEDWATCH PROGRAM CONCERNING BVI PRODUCT. THE UF/IMPORTER REPORT # (B)(4) DESCRIBED A SITUATION WHEN A BOVIE PEN WAS USED DURING PATIENT CARE AND A SPARK IGNITED. PATIENT PULLED HIS FINGER AWAY IMMEDIATELY AND THE CHUCKS PAD BURNED SOME. NO OBVIOUS SIGNS OF INJURY WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471331 ↗
• InjuryJul 31, 2023Fire; Fire

  A CUSTOMER ALLEGED THAT A FIRE WAS IGNITED BY THE CAUTERY. WHILE OXYGEN WAS BEING USED AND THE DRAPE APPEARS TO HAVE CAUGHT ON FIRE BURNING THE PATIENST FACE.

  Patient problems: Burn(s)

  MAUDE report 17430485 ↗
• InjuryApr 28, 2023Fire; Fire

  A CUSTOMER REPORTED "USING THE CAUTERY, A FLAME WAS CREATED THAT BURNED THE PATIENT'S EYELASHES." NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Eye Burn

  MAUDE report 16840373 ↗