Neptune E-SEPRecalls & reported problems across all models
Stryker Corporation · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
6 open recalls name at least one Neptune E-SEP model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 412
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls
- 7
We found 19 models of Neptune E-SEP by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 412 adverse event reports in the FDA's MAUDE database, received between Jun 12, 2018 and Aug 11, 2026 — classified as 28 injuries, 384 malfunctions.
The most frequently reported specific device problem is “Unintended Power Up” (185 reports).
7 FDA recall records name at least one of these models by its device identifier, 6 still open.
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
Neptune E-SEP recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 4, 2024Open, Classified
There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
Z-0370-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Oct 4, 2024Open, Classified
There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
Z-0369-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Oct 4, 2024Open, Classified
There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
Z-0368-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Oct 4, 2024Open, Classified
There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
Z-0367-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Oct 4, 2024Open, Classified
There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
Z-0366-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Oct 4, 2024Open, Classified
There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
Z-0365-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 26, 2020Terminated
Due to a distribution error, product from the affected lot was shipped expired.
Z-1807-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Neptune E-SEP problems
Device problems
- Unintended Power Up185
- Delivered as Unsterile Product49
- Fracture35
- Device Remains Activated33
- Excessive Heating17
- Output below Specifications15
- Fire14
- No Apparent Adverse Event14
Patient problems
- No Clinical Signs, Symptoms or Conditions267
- No Patient Involvement59
- Burn(s)24
- Superficial (First Degree) Burn18
- Insufficient Information17
- No Consequences Or Impact To Patient16
- Full thickness (Third Degree) Burn6
- Laceration(s)5
Neptune E-SEP models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Neptune E-SEP 0703047000ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 recalls131 reports
- Neptune E-SEP 0703047002ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall98 reports
- Neptune E-SEP 0703046000ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES140 reports
- Neptune E-SEP 0703046002ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall9 reports
- Neptune E-SEP 0703047001ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall2 reports
- Neptune E-SEP 0703-165-001ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall1 report
- Neptune E-SEP 0703046001ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall0 reports
- Neptune E-SEP 0703-320-015ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES12 reports
- Neptune E-SEP 0703-315-012ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES6 reports
- Neptune E-SEP 0703-007-070ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Neptune E-SEP 0703-310-010ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Neptune E-SEP 0703005165ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Neptune E-SEP 0703-120-005ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Neptune E-SEP 0703-165-000ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Neptune E-SEP 0703-125-002ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Neptune E-SEP 0703-320-020ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Neptune E-SEP 0703-216-018ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Neptune E-SEP 0703-070-002ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Neptune E-SEP 0703-720-020ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
Recent Neptune E-SEP adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem
It was reported that during use in a procedure at the user facility, a patient sustained a burn while using a Smoke Evac Pencil. It was further reported that the noted wound required medical intervention. The wound was closed by the surgeon. It was further reported that the procedure was completed successfully, without delay.
Patient problems: Burn(s)
MAUDE report 50201872 ↗MalfunctionJul 28, 2026Fire
It was reported that, during a procedure at the user facility, the device tip caught fire. It was reported that the issue had no impact on the patient. It was further reported that there were no adverse consequences and no medical intervention as a result of this event. No information was provided regarding whether the procedure was completed successfully or whether the issue caused a surgical delay.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50052912 ↗MalfunctionMay 15, 2026Unintended Power Up
IT WAS REPORTED THAT DURING A PROCEDURE THE ESEP SAFEAIR PENCIL ACTIVATED WITHOUT PRESSING ANY BUTTONS BY THE SURGEON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR INJURY WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25183877 ↗MalfunctionApr 15, 2026Fire
IT WAS REPORTED THAT DURING THE PROCEDURE AT THE USER FACILITY, THE ESEP PENCIL CAUGHT ON FIRE. IT WAS REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24885179 ↗InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A HYSTERECTOMY PROCEDURE AT THE USER FACILITY, THE ELECTROSURGICAL PENCIL BECAME VERY HOT AND CAUSED A BURN TO THE PATIENT¿S SKIN. IT WAS REPORTED THAT THE BURN WAS ASSESSED AS THIRD TO FOURTH DEGREE DUE TO THE DEPTH OF TISSUE INVOLVEMENT. IT WAS FURTHER REPORTED THAT THE EVENT REQUIRED MEDICAL INTERVENTION. AFFECTED SKIN AND UNDERLYING ADIPOSE TISSUE WERE REMOVED, ADDITIONAL ANTIBIOTICS WERE ADMINISTERED, AND THE BURN MEASURED APPROXIMATELY 8.5 CM BY 2.5 CM. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 24688279 ↗InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A HYSTERECTOMY PROCEDURE AT THE USER FACILITY, THE ELECTROSURGICAL PENCIL BECAME VERY HOT AND CAUSED A BURN TO THE PATIENT¿S SKIN. IT WAS REPORTED THAT THE BURN WAS ASSESSED AS THIRD TO FOURTH DEGREE DUE TO THE DEPTH OF TISSUE INVOLVEMENT. IT WAS FURTHER REPORTED THAT THE EVENT REQUIRED MEDICAL INTERVENTION. AFFECTED SKIN AND UNDERLYING ADIPOSE TISSUE WERE REMOVED, ADDITIONAL ANTIBIOTICS WERE ADMINISTERED, AND THE BURN MEASURED APPROXIMATELY 8.5 CM BY 2.5 CM. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 24688255 ↗MalfunctionMar 4, 2026Unintended Power Up
IT WAS REPORTED THAT DURING INSPECTION THE ESEP PENCIL HAD FAULTY CONTINUITY. THERE WAS NO ASSOCIATED PROCEDURE; NO ADVERSE CONSEQUENCES OR INJURY WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24512862 ↗MalfunctionFeb 9, 2026Fire
IT WAS REPORTED THAT DURING THE PROCEDURE AT THE USER FACILITY, THE ESEP PENCIL CAUGHT ON FIRE. IT WAS ALSO REPORTED THAT A NON STRYKER ELECTRODE WAS USED. NO INFORMATION WAS AVAILABLE IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY OR IF THERE WAS ANY ADVERSE CONSEQUENCES OR SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 24294009 ↗MalfunctionFeb 5, 2026Unintended Power Up; Fire
DURING A PROCEDURE, IT WAS REPORTED THAT THE ESEP PENCIL ACTIVATED WITHOUT THE SURGEON PRESSING ANY BUTTONS, AND THE PENCIL CAUGHT ON FIRE. IT WAS FURTHER REPORTED THAT A NON STRYKER ELECTRODE WAS USED AND THE HOLSTER WAS NOT USED WHEN THE DEVICE GOT CAUGHT ON FIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SIGNIFICANT DELAY, AND NO ADVERSE CONSEQUENCES OR PATIENT INJURY WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24269375 ↗MalfunctionJan 28, 2026Unintended Power Up
IT WAS REPORTED THAT DURING A PROCEDURE THE SMOKE EVAC PENCIL ACTIVATED WITHOUT PRESSING ANY BUTTONS BY THE SURGEON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR INJURY WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24198730 ↗InjuryJan 16, 2026Unintended Power Up
IT WAS REPORTED THAT, DURING USE AT THE USER FACILITY, THE USER DID NOT USE THE HOLSTER AND PLACED THE DEVICE ON THE PATIENT¿S LEG, CAUSING A THIRD-DEGREE BURN. IT WAS FURTHER REPORTED THAT THE PENCIL WAS NOT TURNED ON MANUALLY WHEN PLACED ON THE PATIENT¿S LEG. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT DELAY.
Patient problems: Burn(s)
MAUDE report 24094985 ↗MalfunctionDec 17, 2025Unintended Power Up; Unintended Power Up
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23829308 ↗MalfunctionDec 9, 2025Defective Device
BOVIE WAS PLUGGED INTO MACHINE PROPERLY BUT DID NOT FUNCTION OUT OF PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23756205 ↗MalfunctionDec 1, 2025Unintended Power Up; Unintended Power Up
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23683773 ↗MalfunctionDec 1, 2025Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO ADDITIONAL INFORMATION PROVIDED, THE NON-STRYKER ELECTRODE WAS USED DURING THE SURGERY.
Patient problems: Burn(s)
MAUDE report 23679415 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
- InTouch5 models · 666 reports · 1 recall
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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