MEDLINE INDUSTRIES, INC. ESRK3000Recalls & reported problems
Medline Industries, Inc. · PENCIL,CAUTERY,ROCKER,STERILE,LF,SS · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10080196775972), received between Nov 16, 2023 and Sep 11, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Unintended Power Up” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Unintended Power Up2
- Intermittent Loss of Power1
- Key or Button Unresponsive/not Working1
- Temperature Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Key or Button Unresponsive/not Working
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734213 ↗MalfunctionAug 7, 2026Unintended Power Up
It was reported that the device would not turn off.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50179166 ↗MalfunctionJun 10, 2026Unintended Power Up
IT WAS REPORTED THAT THE CAUTERY TURNED ITSELF ON WHEN NOT IN USE AND WHEN NO ONE HAD ACTIVATED IT/NO BUTTONS WERE BEING PUSHED.
Patient problems: Insufficient Information
MAUDE report 25465906 ↗MalfunctionMay 24, 2026Intermittent Loss of Power
IT WAS REPORTED THAT THE BUTTON ON THE PEN IS DIFFICULT TO PRESS AND THAT THERE IS A VERY SLIGHT DELAY IN THEM LIFTING THEIR FINGER FROM THE BUTTON AND WHEN THE ELECTRICITY ACTUALLY STOPS.
Patient problems: Insufficient Information
MAUDE report 25266395 ↗MalfunctionNov 16, 2023Temperature Problem; Temperature Problem
ACCORDING TO THE FACILITY ON (B)(6)2023 "WHEN TURNED ON, BOVIE TIP CAUGHT FIRE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18148946 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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