Bovie SCH10Recalls & reported problems
Aspen Surgical Products, Inc. · DISPOSABLE SUCTION COAGULATOR, HANDSWITCH, 10 fr X 3m CABLE · Class 2
All models of Bovie (42)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607151006532), received between Jun 29, 2022 and Aug 27, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
- Temperature Problem1
Patient problems
- Superficial (First Degree) Burn2
- Burn(s)1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE COMPLAINANT ALLEGES, "I AM CONTACTING YOU TO NOTIFY YOU OF AN INCIDENT IN WHICH A CUSTOMER WAS BURNED USING ITEM#SCH10.".
Patient problems: Burn(s); Insufficient Information
MAUDE report 20073171 ↗MalfunctionJul 18, 2022Temperature Problem
THE CUSTOMER ALLEGES THAT THE SCH10 WAS BEING USED AND CAUSED A SUPERFICIAL BURN TO THE PHYSICIANS FINGER WHILE DEPRESSING THE HANDSWITCH.
Patient problems: Superficial (First Degree) Burn
MAUDE report 15042791 ↗MalfunctionJun 29, 2022Adverse Event Without Identified Device or Use Problem
THE CUSTOMER ALLEGED THAT WHILE USING SCH10 THE SURGEON RECEIVED A LIGHT BURN THROUGH HIS GLOVE TO HIS FINGER WHILE DEPRESSING THE CAUTERY SWITCH ON TH PENCIL. HE FELT A "ZING" AND IMMEDIATELY RELEASED THE SWITCH.
Patient problems: Superficial (First Degree) Burn
MAUDE report 14854416 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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