Bovie E15646Recalls & reported problems

Aspen Surgical Products, Inc. · 6.5”, 5mm Ball Electrode · Class 2

All models of Bovie (42)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10607151009851), received between Mar 13, 2024 and Mar 13, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Use of Device Problem1

Patient problems

Skin Tears1

Recent adverse event reports

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

MalfunctionMar 13, 2024Use of Device Problem; Use of Device Problem
THE COMPLAINANT ALLEGES, "DURING PROCEDURE, THE DEVICE WAS NOT WORKING PROPERLY, ESCHAR WAS STICKING TO THE ELECTRODE BALL AND TEARS AWAY ESCHAR THAT MADE CERVIX BLED MORE. SUTURE WAS DONE."
Patient problems: Skin Tears
MAUDE report 18899488 ↗

Device details

UDI-DI	`10607151009851`
Brand	Bovie
Model	E15646
Company	Aspen Surgical Products, Inc.
Product code	HGI · Electrocautery, Gynecologic (And Accessories)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 7, 2026

Device type (GMDN): Open-surgery electrosurgical electrode, monopolar, single-use

An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.

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All Electrocautery, Gynecologic (And Accessories) devices →

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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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