ENDOLOOPRecalls & reported problems across all models

We found 2 models of ENDOLOOP by Ethicon Inc. in the FDA's device registry (GUDID). Together they are named in 129 adverse event reports in the FDA's MAUDE database, received between Mar 20, 2018 and Apr 21, 2026 — classified as 9 injuries, 120 malfunctions.

The most frequently reported specific device problem is “Break” (59 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

Most reported ENDOLOOP problems

ENDOLOOP models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ENDOLOOP EZ10G

  SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
  126 reports
• ENDOLOOP EJ10G

  SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
  3 reports

Recent ENDOLOOP adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC APPENDECTOMY ON 1-APR-2026 AND SUTURE WAS USED ON THE APPENDIX. DURING THE PROCEDURE, THE SUTURE BROKE WHILE TIGHTENING THE LOOP. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO DEVICE WILL BE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940596 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE OPERATION, A RUPTURE OCCURRED WHILE USING THE APPENDICEAL LIGATOR. CHANGED ANOTHER ONE TO COMPLETE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24705821 ↗
• MalfunctionMar 6, 2026Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PEDIATRIC SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE CAME OFF (SLIPPED OUT) WHEN THE BREAK POINT WAS BROKEN. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533121 ↗
• MalfunctionFeb 27, 2026Break; Product Quality Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A SUTURE LOOP WAS USED. HAD A PROBLEM WITH OUR ENDOLOOP I HAVE THE PACKAGES AND THE REST OF THE BOX TO RETURN TO THE COMPANY FOR THEM TO CHECK. THE ONE STUCK WHILE TRYING TO DEPLOY THEN THE LOOP BROKE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470159 ↗
• MalfunctionJan 9, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE LIGATURE BROKE DURING THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24028508 ↗
• MalfunctionJan 9, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE LIGATURE BROKE DURING THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24028404 ↗
• MalfunctionDec 31, 2025Break; Product Quality Problem; Break; Product Quality Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, NURSE MENTIONED SOMETHING ON THE STRAND BROKE OFF AND THE STRAND CANNOT BE PULLED. SUTURE WAS BROKEN. PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936135 ↗
• MalfunctionNov 20, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, THAT THERE WERE MULTIPLE FAILURES. THE FIRST DEVICE BROKE OFF, THE SECOND AND THIRD WITH FLIMSY COMPONENTS. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606629 ↗
• MalfunctionNov 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, THAT THERE WERE MULTIPLE FAILURES. THE FIRST DEVICE BROKE OFF, THE SECOND AND THIRD WITH FLIMSY COMPONENTS. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606624 ↗
• MalfunctionNov 20, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, THAT THERE WERE MULTIPLE FAILURES. THE FIRST DEVICE BROKE OFF, THE SECOND AND THIRD WITH FLIMSY COMPONENTS. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606620 ↗
• MalfunctionOct 10, 2025Delivered as Unsterile Product; Device Markings/Labelling Problem; Delivered as Unsterile Product; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REPRESENTATIVE REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A HOLE WAS OBSERVED IN THE PACKAGING, PREVENTING VALIDATION OF STERILITY. NO PATIENT WAS INVOLVED. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23270411 ↗
• MalfunctionOct 10, 2025Delivered as Unsterile Product; Device Markings/Labelling Problem; Delivered as Unsterile Product; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REPRESENTATIVE REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A HOLE WAS OBSERVED IN THE PACKAGING, PREVENTING VALIDATION OF STERILITY. NO PATIENT WAS INVOLVED. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23270397 ↗
• MalfunctionOct 10, 2025Delivered as Unsterile Product; Device Markings/Labelling Problem; Delivered as Unsterile Product; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REPRESENTATIVE REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A HOLE WAS OBSERVED IN THE PACKAGING, PREVENTING VALIDATION OF STERILITY. NO PATIENT WAS INVOLVED. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23270392 ↗
• MalfunctionSep 26, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC APPENDECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING A LAPAROSCOPIC APPENDECTOMY, THE SUTURE CAME OFF WHEN TRIED TO LIGATURE AND THE TIP OF THE CANULA AT THE BREAK POINT WAS BROKEN. IT WAS USED ON APPENDIX. ANOTHER DEVICE WAS USED AND TRIED THE SAME OPERATION, BUT THE SUTURE CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. TWO DEVICES WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23158308 ↗
• MalfunctionSep 26, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC APPENDECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING A LAPAROSCOPIC APPENDECTOMY, THE SUTURE CAME OFF WHEN TRIED TO LIGATURE AND THE TIP OF THE CANULA AT THE BREAK POINT WAS BROKEN. IT WAS USED ON APPENDIX. ANOTHER DEVICE WAS USED AND TRIED THE SAME OPERATION, BUT THE SUTURE CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. TWO DEVICES WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23158302 ↗

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