BovieRecalls & reported problems across all models
Aspen Surgical Products, Inc. · 42 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 100
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 42 models of Bovie by Aspen Surgical Products, Inc. in the FDA's device registry (GUDID). Together they are named in 100 adverse event reports in the FDA's MAUDE database, received between Oct 5, 2017 and Aug 12, 2026 — classified as 2 injuries, 98 malfunctions.
The most frequently reported specific device problem is “Break” (17 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Bovie problems
Device problems
- Break17
- Adverse Event Without Identified Device or Use Problem12
- Fire9
- Failure to Power Up7
- Complete Loss of Power4
- Output Problem4
- Overheating of Device4
- Sparking4
Patient problems
- No Clinical Signs, Symptoms or Conditions50
- Superficial (First Degree) Burn21
- Insufficient Information8
- Burn(s)7
- Burn, Thermal6
- No Consequences Or Impact To Patient4
- Arrhythmia1
- Electric Shock1
Bovie models
42 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bovie AA01Unit, Cautery, Thermal, Battery-Powered23 reports
- Bovie AA05Unit, Cautery, Thermal, Battery-Powered10 reports
- Bovie A1250SElectrosurgical, Cutting & Coagulation & Accessories6 reports
- Bovie ESRSCElectrosurgical, Cutting & Coagulation & Accessories4 reports
- Bovie AA21Unit, Cautery, Thermal, Battery-Powered4 reports
- BOVIE ES37Electrocautery, Gynecologic (And Accessories)4 reports
- Bovie ESRSElectrosurgical, Cutting & Coagulation & Accessories3 reports
- Bovie SCH10Electrosurgical, Cutting & Coagulation & Accessories3 reports
- Bovie SCH08Electrosurgical, Cutting & Coagulation & Accessories2 reports
- Bovie SCH12Electrosurgical, Cutting & Coagulation & Accessories2 reports
- Bovie AA01XUnit, Cautery, Thermal, Battery-Powered2 reports
- Bovie AA03Unit, Cautery, Thermal, Battery-Powered2 reports
- Bovie ES10Electrocautery, Gynecologic (And Accessories)2 reports
- BOVIE ES39Electrocautery, Gynecologic (And Accessories)2 reports
- Bovie A2350Electrosurgical, Cutting & Coagulation & Accessories2 reports
- BOVIE A1252CElectrosurgical, Cutting & Coagulation & Accessories2 reports
- Bovie A940Electrosurgical, Cutting & Coagulation & Accessories2 reports
- Bovie 0003Stimulator, Nerve1 report
- Bovie ESP1HNElectrosurgical, Cutting & Coagulation & Accessories1 report
- Bovie SERFTubing, Noninvasive1 report
- Bovie ES11RElectrosurgical, Cutting & Coagulation & Accessories1 report
- BOVIE ES58TElectrosurgical, Cutting & Coagulation & Accessories1 report
- Bovie SCF12Electrosurgical, Cutting & Coagulation & Accessories1 report
- BOVIE A807Electrocautery, Gynecologic (And Accessories)1 report
- BOVIE DEL1Electrosurgical, Cutting & Coagulation & Accessories1 report
- Bovie ES04Electrocautery, Gynecologic (And Accessories)1 report
- Bovie ESP1Electrosurgical, Cutting & Coagulation & Accessories1 report
- Bovie ES43Electrocautery, Gynecologic (And Accessories)1 report
- BOVIE H103Electrosurgical, Cutting & Coagulation & Accessories1 report
- BOVIE H104Electrosurgical, Cutting & Coagulation & Accessories1 report
- BOVIE H121Electrosurgical, Cutting & Coagulation & Accessories1 report
- Bovie ESRECElectrosurgical, Cutting & Coagulation & Accessories1 report
- Bovie A1204PElectrosurgical, Cutting & Coagulation & Accessories1 report
- BOVIE 0010Burr, Corneal, Battery-Powered1 report
- BOVIE A1204PElectrosurgical, Cutting & Coagulation & Accessories1 report
- Bovie A802EUElectrosurgical, Cutting & Coagulation & Accessories1 report
- Bovie A2250-LOANERElectrosurgical, Cutting & Coagulation & Accessories1 report
- Bovie SE02-220Apparatus, Exhaust, Surgical1 report
- Bovie IDS-310Electrosurgical, Cutting & Coagulation & Accessories1 report
- Bovie E15646Electrocautery, Gynecologic (And Accessories)1 report
- Bovie E15644Electrocautery, Gynecologic (And Accessories)1 report
- Bovie A3250Electrosurgical, Cutting & Coagulation & Accessories1 report
Recent Bovie adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2026Circuit Failure
Patient problems: Burn(s)
MAUDE report 50226804 ↗MalfunctionJun 18, 2026Unexpected Shutdown
COMPLAINANT ALLEGES "DOES NOT LAST LONG, WE HAVE TO USE 2 PER SURGERY. WE FEAR THAT SHORTLY, THEY WILL STOP WORKING BEFORE THEY ARE EVEN USED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25549835 ↗MalfunctionMay 29, 2026Flare or Flash
COMPLAINANT ALLEGES "WHEN USING A BIPOLAR CATHETER TO STOP BLEEDING FROM A PATIENT'S EYELID, IT IGNITED AT THE TIP. THE PATIENT'S UPPER EYELASHES WERE BURNED."
Patient problems: Superficial (First Degree) Burn
MAUDE report 25337080 ↗InjuryMay 27, 2026Grounding Malfunction
COMPLAINANT ALLEGES "WE PURCHASED A BRAND NEW BOVIE FOR MFI MEDICAL. THE GROUNDING PLATE HAD CAUSED A BURN IN ONE PATIENT."
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 25306452 ↗MalfunctionApr 22, 2026Failure to Power Up
COMPLAINANT ALLEGES "DURING THE SURGERY ON MARCH 24, THE CAUTERY WAS OPENED AND FOUND WITH THE CAP DETACHED. WHEN THE SWITCH WAS PRESSED, THE DEVICE DID NOT RESPOND AT ALL. NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT WAS REPORTED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24957024 ↗MalfunctionApr 3, 2026Failure to Power Up
COMPLAINANT ALLEGES "TO BEGIN CAUTERIZATION, IT IS NECESSARY TO PRESS THE GREEN BUTTON AFTER OPENING THE LID. HOWEVER, IN THIS CASE, THE BUTTON WAS ALREADY RECESSED FROM THE BEGINNING, MAKING IT IMPOSSIBLE TO INITIATE THE CAUTERIZATION. THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT. NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT OCCURRED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24777415 ↗MalfunctionMar 30, 2026Insufficient Heating
COMPLAINANT ALLEGES "THE ARTIFICIAL BLOOD VESSEL COULD NOT BE SEVERED DUE TO INSUFFICIENT THERMAL CONDUCTIVITY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24714233 ↗MalfunctionMar 24, 2026Failure to Power Up
COMPLAINANT ALLEGES "THE CAUTERY DID NOT POWER ON WHEN ACTIVATED. THIS OCCURRED DURING HEART SURGERY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24675696 ↗MalfunctionFeb 25, 2026Failure to Power Up
COMPLAINANT ALLEGES "THE CAUTERY FAILED TO POWER ON WHEN THE USER ATTEMPTED TO SWITCH IT ON. THIS OCCURRED DURING CARDIAC SURGERY. NO DELAY OR PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24445580 ↗MalfunctionFeb 19, 2026Intermittent Loss of Power
COMPLAINANT ALLEGES "THE PHYSICIAN WAS PERFORMING A PROCEDURE TO IMPLANT A VASCULAR GRAFT. DURING THE GRAFT PREPARATION USING THE SUBJECT DEVICE (AA01), THE HEATING FUNCTION AT THE DISTAL TIP GRADUALLY WEAKENED, MAKING IT IMPOSSIBLE TO CONTINUE THE GRAFT SHAPING OPERATION. THE USER REPLACED THE DEVICE WITH ANOTHER UNIT OF THE SAME MODEL AND CONTINUED THE PROCEDURE WITHOUT FURTHER ISSUES. THERE WAS NO HARM TO THE PATIENT, AND NO PROCEDURAL DELAY WAS REPORTED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24390469 ↗MalfunctionFeb 4, 2026Complete Loss of Power
COMPLAINANT ALLEGES "WE WOULD LIKE TO INFORM YOU OF A NON-COMPLIANCE ISSUE ENCOUNTERED ON (B)(6) 2025, FOR ONE OF OUR CUSTOMERS CONCERNING ONE OF YOUR PRODUCTS. THE REPORTED ANOMALY IS AS FOLLOWS: THERMOCUTTER MALFUNCTION OBSERVED ON THREE DEVICES USED SUCCESSIVELY FROM THE SAME BATCH."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24260814 ↗MalfunctionJan 8, 2026Device Remains Activated
COMPLAINANT ALLEGES "THE CAUTERIZER REMAINED ACTIVE, AND FURTHER INVESTIGATION REVEALED A LEAKING BATTERY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24011968 ↗MalfunctionJan 6, 2026Complete Loss of Power
COMPLAINANT ALLEGES "ERROR CODE E-4 - WOULD NOT WORK DURING PROCEDURE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23980337 ↗MalfunctionDec 29, 2025Complete Loss of Power; Complete Loss of Power
COMPLAINANT ALLEGES "NOT PRODUCING POWER TO BOVIE HANDLE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23916336 ↗MalfunctionDec 22, 2025Complete Loss of Power; Complete Loss of Power
COMPLAINANT ALLEGES "ISSUE - DEVICE WIL SHUT OFF DURING USE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23867530 ↗
Other Aspen Surgical Products, Inc. products
All Aspen Surgical Products, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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