Bovie SE02-220Recalls & reported problems

Aspen Surgical Products, Inc. · SMOKE SHARK II 120V-220V - SMOKE EVACUATOR · 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 10607151008304), received between Jan 3, 2024 and Jan 3, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (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

Activation Failure1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionJan 3, 2024Activation Failure; Activation Failure
THE CUSTOMER ALLEGED THAT THE SMOKE SHARK STOPPED WORKING 20 MINUTES INTO THE PROCEDURE. IT WAS CONFIRMED THAT THE PROCEDURE HAD TO BE CANCELED AND RESCHEDULED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18436848 ↗

Device details

UDI-DI	`10607151008304`
Brand	Bovie
Model	SE02-220
Company	Aspen Surgical Products, Inc.
Product code	FYD · Apparatus, Exhaust, Surgical
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 30, 2025

Device type (GMDN): Surgical plume evacuation system

A mains electricity (AC-powered) assembly of devices intended to capture smoke generated during open surgical procedures involving tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). It captures the plume (smoke composed of carbonized cell fragments, water vapour, and hydrocarbons from vaporized tissue) near its origin before it becomes dispersed and causes surgical staff respiratory exposure. It consists of a capture tube or wand and four elements to evacuate smoke: user interface, filters, suction source, and exhaust. The system may be mobile (on wheels) and used during closed surgical procedures (e.g., endoscopy, laparoscopy) to clear the view. See also: Gas/fume evacuation system; Anaesthetic gas scavenging unit; Suction system filter, plume particulate; Orthopaedic cement fume evacuator; Surgical plume evacuation system tube

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ZIP Pen 252510
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4 reports
MEGADYNE 2255J
Megadyne Medical Products, Inc. · APPARATUS, EXHAUST, SURGICAL
4 reports
RapidVac SE3690ZD
Covidien LP · APPARATUS, EXHAUST, SURGICAL
1 report

All Apparatus, Exhaust, Surgical 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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