EnsealRecalls & reported problems across all models
Ethicon Endo-Surgery, LLC · 24 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,360
- Deaths reported
- 5
- Injuries reported
- 123
- Recalls
- 0
We found 24 models of Enseal by Ethicon Endo-Surgery, LLC in the FDA's device registry (GUDID). Together they are named in 1,360 adverse event reports in the FDA's MAUDE database, received between Jul 18, 2017 and Sep 28, 2026 — classified as 5 deaths, 123 injuries, 1,232 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (487 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 Enseal problems
Device problems
- Difficult to Open or Close487
- Detachment of Device or Device Component236
- Material Integrity Problem178
- Break106
- Material Separation89
- Adverse Event Without Identified Device or Use Problem60
- No Apparent Adverse Event57
- Activation, Positioning or Separation Problem52
Patient problems
- No Clinical Signs, Symptoms or Conditions784
- No Consequences Or Impact To Patient444
- Hemorrhage/Blood Loss/Bleeding74
- Insufficient Information17
- Hematoma15
- No Code Available9
- Blood Loss8
- Burn(s)6
Enseal models
24 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Enseal NSLX137CELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)3 deaths344 reports
- Enseal NSLG2C35ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES211 reports
- Enseal NSLG2C35AELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES163 reports
- Enseal NSLG2S35ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES145 reports
- Enseal NSLG2S35AELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES113 reports
- Enseal NSLX125CElectrosurgical, cutting & coagulation & accessories2 deaths67 reports
- Enseal ETRIO335HElectrosurgical, cutting & coagulation & accessories38 reports
- Enseal NSLG2C25ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES37 reports
- Enseal NSLG2S45AELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES34 reports
- Enseal NSLG2C45AELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES32 reports
- Enseal NSLX145CElectrosurgical, cutting & coagulation & accessories32 reports
- Enseal NSLG2S25ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES24 reports
- Enseal NSEAL535RHElectrosurgical, cutting & coagulation & accessories22 reports
- Enseal NSLG2S45ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES20 reports
- Enseal NSEAL545RHElectrosurgical, cutting & coagulation & accessories16 reports
- Enseal ETRIO325HElectrosurgical, cutting & coagulation & accessories13 reports
- Enseal NSLG2C45ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES12 reports
- Enseal NSEAL525RHElectrosurgical, cutting & coagulation & accessories10 reports
- Enseal NSLG2C14ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES7 reports
- Enseal NSLG2S14ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES7 reports
- Enseal NSEALX22LElectrosurgical, cutting & coagulation & accessories5 reports
- Enseal ETRIO345HElectrosurgical, cutting & coagulation & accessories4 reports
- Enseal ETRIO314HElectrosurgical, cutting & coagulation & accessories3 reports
- Enseal NSEAL514RHElectrosurgical, cutting & coagulation & accessories1 report
Recent Enseal adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Material Integrity Problem; Appropriate Device Problem Term/Code Not Available
It was reported that some of the black insulating material on the shaft of the instrument came off inside the patient during a laparoscopic anterior resection. The surgeon was unable to retrieve the piece of insulation. He does not anticipate that this will cause any issues for the patient.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 50916529 ↗InjurySep 28, 2026Failure to Read Input Signal; Adverse Event Without Identified Device or Use Problem
It was reported that, during Vaginal Natural Orifice Transluminal Endoscopic Surgery, the doctor grasped the right uterosacral ligament with forceps and coagulate the area immediately near adjacent to the right uterosacral ligament using ENSEAL. An error message like ¿metal error¿ was displayed, so the device was moved a few millimeters away from the forceps and was reactivated. It felt like it took longer than usual for the completion sound to play. After that, ENSEAL completed the operation without any problems. The inner surface of the right labium minus presented a condition resembling a burn. The same device was used as is to complete the case. No further information is available.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 50916182 ↗MalfunctionSep 17, 2026Difficult to Open or Close; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808536 ↗MalfunctionSep 17, 2026Difficult to Open or Close
It was reported that during laparoscopic urological procedure after clamping the thick tissue, the jaws could no longer be opened. Main device was taken out, and the surgery was performed using an electric knife instead. No pieces were left inside the patient. There were no adverse consequences to the patient. No further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808521 ↗MalfunctionSep 17, 2026Difficult to Open or Close; Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808505 ↗MalfunctionSep 17, 2026Difficult to Open or Close; Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808466 ↗MalfunctionSep 17, 2026Difficult to Open or Close; No Apparent Adverse Event
It was reported that during a Radical Prostatectomy procedure when clamping the tissue near prostatic artery, the malfunction occurred that the jaws did not open. The surrounding tissues were dissected using an electrosurgical knife, and the operation was performed using an electrosurgical knife. No pieces were fell into the patient. There were no adverse consequences to the patient. No further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808416 ↗MalfunctionSep 17, 2026Difficult to Open or Close; No Apparent Adverse Event
It was reported that during an unknown procedure initially the device was performing fine. Then after seal and press cut on the device, it stuck. Jaw failed to open on the device. Able to open the jaw of the device by force when outside of patient body, by inserting pull force on the closing handle. A bipolar and normal scissors were used to remove the device from the uterus. Another device was used to complete the surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808371 ↗MalfunctionSep 10, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720378 ↗MalfunctionSep 8, 2026Detachment of Device or Device Component
It was reported that during hysterectomy procedure the distal jaw broke at the hinge. Opened a new one and proceeded with the procedure. No negative patient outcomes.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50672846 ↗MalfunctionSep 3, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588396 ↗MalfunctionAug 21, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50375365 ↗MalfunctionAug 6, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50164951 ↗MalfunctionJul 31, 2026Difficult or Delayed Activation
It was reported that during a Total Laparoscopic Hysterectomy, the tip of the device would not to activate. The procedure was completed using a replacement device. The tissue was not grasped, so there was no impact on the patient. There were no adverse consequences to the patient. No further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50098557 ↗MalfunctionJun 29, 2026Mechanical Jam
IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE KNIFE ONLY RETURNED UNTIL ABOUT HALFWAY DURING USE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25652675 ↗
Other Ethicon Endo-Surgery, LLC products
- Harmonic ACE9 models · 12,862 reports
- ECHELON FLEX7 models · 9,393 reports · 1 recall
- Harmonic13 models · 8,752 reports · 2 recalls
- ECHELON ENDOPATH31 models · 6,543 reports · 2 recalls
- LIGACLIP26 models · 3,254 reports
- ENDOPATH37 models · 2,785 reports
- ECHELON CIRCULAR4 models · 2,532 reports
- ECHELON Flex ENDOPATH7 models · 2,334 reports
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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