ENDOPATH XCELRecalls & reported problems across all models
Ethicon Endo-Surgery, LLC · 25 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 796
- Deaths reported
- 3
- Injuries reported
- 49
- Recalls
- 0
We found 25 models of ENDOPATH XCEL by Ethicon Endo-Surgery, LLC in the FDA's device registry (GUDID). Together they are named in 796 adverse event reports in the FDA's MAUDE database, received between Sep 19, 2013 and Sep 29, 2026 — classified as 3 deaths, 49 injuries, 744 malfunctions.
The most frequently reported specific device problem is “Crack” (328 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 ENDOPATH XCEL problems
Device problems
- Crack328
- Material Integrity Problem154
- Delivered as Unsterile Product98
- Manufacturing, Packaging or Shipping Problem34
- Break32
- Gas/Air Leak29
- Mechanical Problem21
- Component or Accessory Incompatibility19
Patient problems
- No Clinical Signs, Symptoms or Conditions611
- No Consequences Or Impact To Patient137
- Foreign Body In Patient27
- Insufficient Information10
- Hemorrhage/Blood Loss/Bleeding5
- No Code Available5
- Pain3
- Unspecified Tissue Injury3
ENDOPATH XCEL models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ENDOPATH XCEL B12LTLaparoscope, general & plastic surgery297 reports
- ENDOPATH XCEL B5LTLaparoscope, general & plastic surgery1 death86 reports
- ENDOPATH XCEL CB5LTLaparoscope, general & plastic surgery1 death75 reports
- ENDOPATH XCEL B12SRTLaparoscope, general & plastic surgery68 reports
- ENDOPATH XCEL CB12LTLaparoscope, general & plastic surgery59 reports
- ENDOPATH XCEL D12LTLaparoscope, general & plastic surgery36 reports
- ENDOPATH XCEL D11LTLaparoscope, general & plastic surgery1 death33 reports
- ENDOPATH XCEL B11LTLaparoscope, general & plastic surgery23 reports
- ENDOPATH XCEL B5STLaparoscope, general & plastic surgery22 reports
- ENDOPATH XCEL B12XTLaparoscope, general & plastic surgery19 reports
- ENDOPATH XCEL H12LPLaparoscope, general & plastic surgery16 reports
- ENDOPATH XCEL B15LTLaparoscope, general & plastic surgery12 reports
- ENDOPATH XCEL D5LTLaparoscope, general & plastic surgery12 reports
- ENDOPATH XCEL CB5STLaparoscope, general & plastic surgery6 reports
- ENDOPATH XCEL D12XTLaparoscope, general & plastic surgery6 reports
- ENDOPATH XCEL B5XTLaparoscope, general & plastic surgery5 reports
- ENDOPATH XCEL CB11LTLaparoscope, general & plastic surgery5 reports
- ENDOPATH XCEL B8LTLaparoscope, general & plastic surgery4 reports
- ENDOPATH XCEL B12LTHLaparoscope, general & plastic surgery3 reports
- ENDOPATH XCEL D5STLaparoscope, general & plastic surgery3 reports
- ENDOPATH XCEL K11LTLaparoscope, general & plastic surgery2 reports
- ENDOPATH XCEL B11LPHLaparoscope, general & plastic surgery1 report
- ENDOPATH XCEL B12LPLaparoscope, general & plastic surgery1 report
- ENDOPATH XCEL K12LTLaparoscope, general & plastic surgery1 report
- ENDOPATH XCEL K5LTLaparoscope, general & plastic surgery1 report
Recent ENDOPATH XCEL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Manufacturing, Packaging or Shipping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935647 ↗MalfunctionSep 28, 2026Manufacturing, Packaging or Shipping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918429 ↗MalfunctionSep 24, 2026Material Integrity Problem
It was reported that, during an unknown surgery, a thin black part came off during the procedure. 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 50881732 ↗MalfunctionSep 21, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846409 ↗MalfunctionSep 21, 2026Material Integrity Problem
It was reported that during an unknown surgery, the trocar valve was damaged and there was resistance when inserting and removing forceps. No pieces fell into the patient. Another device was used to complete the case because the resistance suddenly increased. There were no adverse consequences to the patient. No further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846162 ↗MalfunctionSep 21, 2026Delivered as Unsterile Product
It was reported that during a Proctocolectomy surgery, before used on the patient, noted the packing was damaged. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information could be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838217 ↗MalfunctionSep 15, 2026Adverse Event Without Identified Device or Use Problem
it was reported that during an Unknown procedure the defect noticed during surgery at the internal tip of the port. When brought to surgeon's attention,they stated that many have been why placing the port felt hard. Curve noticed outwards on the lipof the device.Patient Outcome/Consequences: N/A.No further information available as reporter details have not been disclosed (confidential).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50772252 ↗MalfunctionSep 11, 2026Material Integrity Problem
It was reported that during an Unknown procedure the Universal hap loose & trocar loosened. It was reported that during the surgery, universal hap loosened. Besides, the trocar was found to be loose. Changed the new one to complete surgery. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734093 ↗MalfunctionSep 3, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50591666 ↗MalfunctionSep 1, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50541817 ↗MalfunctionAug 18, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50299260 ↗MalfunctionAug 10, 2026Manufacturing, Packaging or Shipping Problem
It was reported that during an Unknown surgery, opened the packing noted the device was damaged. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information could be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50194153 ↗MalfunctionJun 11, 2026Material Integrity Problem
IT WAS REPORTED THAT DURING A BARIATRIC PROCEDURE (GASTRIC BYPASS), THE TROCAR WAS PLACED AND USED ACCORDING TO STANDARD INSTRUCTIONS FOR USE. THE WHITE PLASTIC LUMEN IS LOCATED AT THE PROXIMAL OPENING OF THE TROCAR. AFTER PROLONGED USE OF 5 MM INSTRUMENTS WITHIN A 12 MM TROCAR, THE WHITE LUMEN REMAINED DISPLACED OFF-CENTER. UNDER NORMAL CONDITIONS, THE LUMEN SHOULD RETURN AUTOMATICALLY TO ITS ORIGINAL POSITION, IN WHICH IT IS NO LONGER VISIBLE AT THE OPENING. DUE TO THIS MALFUNCTION, THE LUMEN DID NOT IMMEDIATELY RETURN TO ITS NORMAL POSITION AFTER INSTRUMENT REMOVAL. AS A RESULT, INSERTION OF A 12 MM INSTRUMENT (SUCH AS A STAPLER) WAS NOT POSSIBLE WITHOUT ADDITIONAL MANIPULATION. THE LUMEN FIRST HAD TO BE MANUALLY REPOSITIONED (PUSHED BACK) BEFORE THE STAPLER COULD BE INSERTED AND POSITIONED CORRECTLY. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25475434 ↗MalfunctionMay 29, 2026Gas/Air Leak; Material Integrity Problem
IT WAS REPORTED THAT, DURING AN UNKNOWN LAPAROSCOPY, AIR LEAKED FROM THE INTERNAL VALVE, AND PNEUMOPERITONEUM COULD NOT BE MAINTAINED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25334819 ↗MalfunctionMay 21, 2026Material Integrity Problem
B12LT USED IN A LAP CHOLE CASES. RUBBER VALVE DETACHED FROM TROCAR AND LANDED IN PATIENT'S ABDOMINAL SPACE, WHEN SURGEON WAS TRYING TO INSERT A GAUZE THROUGH THE TROCAR. FULL PIECE OF RUBBER VALVE WAS RECOVERED, CASE PROCEEDED WITH SECOND B12LT. ENDOPATH XCEL BLADELESS TROCAR (B12LT): SIDE AFFECTED: NOT APPLICABLE REASON PRODUCT IS NOT AVAILABLE: AVAILABLE LIST ANY J&J PRODUCTS THAT WERE UTILIZED DURING THE CASE BUT DID NOT CONTRIBUTE TO THE REPORTED EVENT. WAS THERE ANY REPORTED PATIENT OR USER HARM? NO WAS THERE A SIGNIFICANT DELAY? IF AVAILABLE, PROVIDE THE PRODUCT ORDER NUMBER (PO).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25247450 ↗
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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