Endo BagRecalls & reported problems across all models

We found 2 models of Endo Bag by Covidien LP in the FDA's device registry (GUDID). Together they are named in 41 adverse event reports in the FDA's MAUDE database, received between Oct 13, 2017 and Aug 18, 2026 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (36 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 Endo Bag problems

Endo Bag models

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

• Endo Bag 25030

  Laparoscope, general & plastic surgery
  31 reports
• Endo Bag 25040

  Laparoscope, general & plastic surgery
  10 reports

Recent Endo Bag adverse event reports

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

• MalfunctionAug 18, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50311442 ↗
• MalfunctionAug 18, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50311424 ↗
• 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 ↗
• MalfunctionMay 13, 2026Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, UPON INSERTING THE RETRIEVAL BAG INTO THE CAVITY AND ATTEMPTING TO RETRIEVE THE SPECIMEN, THE BAG RUPTURED. THE DOCTOR REQUESTED A REPLACEMENT, WHICH WAS PROVIDED AND FUNCTIONED WITHOUT ANY DEFECTS. NO FRAGMENTS FROM THE RUPTURED BAG FELL INTO THE CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25165298 ↗
• 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 ↗
• MalfunctionDec 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE BAG TORE. THE ISSUE WAS RESOLVED BY OPENING ANOTHER DEVICE AND RETRIEVING IT WITH A NEW ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760339 ↗
• MalfunctionNov 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE BAG RUPTURED DURING THE EXTRACTION OF THE GALLBLADDER, RESULTING IN GALLSTONES AND BILE SPILLING INTO THE ABDOMINAL CAVITY. THIS REQUIRED ASPIRATION, LAVAGE, AND REMOVAL OF THE SPILLED CONTENTS WITH ANOTHER EXTRACTION BAG. THE SURGICAL TIME WAS EXTENDED BY APPROXIMATELY 1 HOUR AND 30 MINUTES DUE TO THESE ISSUES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23523507 ↗
• 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 16, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC CHOLECYSTECTOMY, THE BAG TORE. A NEW, UNOPENED DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 23066594 ↗
• MalfunctionSep 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY , SPECIMEN BAG GOT RIPPED UPON REMOVAL FROM PATIENT. IT WAS NOTED THAT NOTHING WAS NEEDED TO BE DONE. THE SPECIMEN WAS STILL WITHIN THE POUCH AND THE BAG WAS INTACT. THE PROCEDURE CONTINUED AS PLANNED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22954509 ↗
• MalfunctionJan 13, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, WHEN IN THE ABDOMINAL CAVITY, WHEN THE BAG WAS REMOVED FROM THE TROCAR, THE BAG OPENED. TO RESOLVE THE ISSUE, THE SURGEON REPLACED ANOTHER DEVICE THAT COULD REMOVE THE SPECIMEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137454 ↗
• MalfunctionDec 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC CHOLECYSTECTOMY, THE BAG BROKE WHEN THE SURGEON TRIED TO PUT IN THE SPECIMEN FOR EXTRACTION. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852965 ↗
• 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 14, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN ATTEMPTING TO REMOVED THE GALLBLADDER, THE BAG RUPTURED. PATIENT INCISION WAS KEPT OPEN AND PACKED AS PREVENTATIVE MEASURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18909533 ↗
• 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 ↗

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