Endo Bag 25040Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884523000979), received between Apr 25, 2018 and Jun 12, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (8 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC OVARIAN CYST SURGERY, AT THE LAST STEP WHEN REMOVING THE SPECIMEN, THE DEVICE'S RUBBER BAND TORE AND FELL INTO THE ABDOMINAL CAVITY. THE RUBBER BAND WAS REMOVED BY THE SURGEON. THE DEVICE WAS CHANGED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25490596 ↗
• MalfunctionMar 30, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE BAG WAS FOUND TO BE OPENED AT THE BOTTOM AS IT WAS INTRODUCED INTO THE CAVITY. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24712600 ↗
• MalfunctionOct 30, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY, THE BAG RUPTURED WHILE EXTRACTING THE APPENDIX. THE PRODUCT WAS REPLACED WITH ANOTHER TYPE OF DEVICE TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430135 ↗
• MalfunctionSep 23, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, WHEN REMOVING THE APPENDIX THE BAG BROKE. A NEW INPUT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278649 ↗
• MalfunctionMar 7, 2024Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN REMOVING THE SPECIMEN, THE BAG TORE AND THE SPECIMEN AND BAG FELL INTO THE PATIENT. THE BAG WAS REMOVED AND REPLACED WITH ANOTHER SPECIMEN RETRIEVAL BAG TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862649 ↗
• MalfunctionApr 26, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE BAG TORE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14215122 ↗
• MalfunctionOct 5, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, ON A MYOMA PROCEDURE, THE BAG WAS BROKEN. THE USER CHANGED TO A NEW DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10627136 ↗
• MalfunctionJul 9, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, THE BAG TORE ALONG THE SEAM WHEN TRYING TO REMOVE THE SPECIMEN FROM THE ABDOMEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8771687 ↗
• MalfunctionNov 14, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC APPENDECTOMY WHEN REMOVING THE TISSUE, THE SURGEON PLACED THE APPENDIX IN THE BAG, HOWEVER THE APPENDIX WAS NOT SECURED IN THE BAG. THE BAG WAS CHECKED AND HOLE WAS FOUND IN THE BAG. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8067931 ↗
• MalfunctionApr 25, 2018Torn Material; Torn Material

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE WAS GIVEN AN IMPRESSION TO TEAR AROUND THE RING THOUGH THERE WAS NO OVER PRESSURE PERFORMED AT THAT TIME. REPLACED BY A NEW DEVICE FROM ANOTHER LOT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7458237 ↗