Endo Bag 25030Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10884523000962), received between Oct 13, 2017 and Aug 18, 2026 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (28 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 25 most recent of 31 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 17, 2024Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE BAG COMPLETELY DETACHED FROM THE RING. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 18528614 ↗
• MalfunctionDec 29, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE BAG BROKE.

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

  MAUDE report 18422070 ↗
• MalfunctionDec 14, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN THE DEVICE WAS REMOVED FROM THE ORIGINAL PACKAGING, THE DEVICE WAS BROKEN. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18327342 ↗
• MalfunctionDec 5, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SURGERY, THE BOTTOM OF THE BAG WAS TORN. THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18270061 ↗
• MalfunctionNov 16, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHILE SPECIMEN REMOVAL, THE SPECIMEN BAG RUPTURED WHEN THE SURGEON PULLED ON IT. THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 18156887 ↗
• MalfunctionApr 3, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC CHOLECYSTECTOMY, THE BAG BURST. THE SURGEON WAS BEING GENTLE ON EXTRACTION AND NO INSTRUMENT MANIPULATION TO THE BAG OR NEAR THE AREA WHERE THE HOLES OCCURRED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 16668564 ↗
• MalfunctionApr 3, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC CHOLECYSTECTOMY, THE BAG BURST. THE SURGEON WAS BEING GENTLE ON EXTRACTION AND NO INSTRUMENT MANIPULATION TO THE BAG OR NEAR THE AREA WHERE THE HOLES OCCURRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16668521 ↗
• MalfunctionApr 3, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE SURGEON WAS BEING GENTLE ON EXTRACTION AND NO INSTRUMENT MANIPULATION BUT THE BAG BURST. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16666036 ↗
• MalfunctionFeb 20, 2023Detachment 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, ON A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN THE REMOVED GALLBLADDER WAS TAKEN OUT, THE BAG GOT TORN IN THE MIDDLE. IT WAS STATED THAT THE GALLSTONES WERE TOO LARGE. THE BAG PART BROKE AND FELL INTO THE PATIENT¿S CAVITY. THE TORN PIECES OF THE BAG WERE REMOVED, AND THE GALLSTONES WERE COLLECTED BY USING INSTRUMENTS SUCH AS FORCEPS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16405712 ↗
• MalfunctionDec 8, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE BAG OF THE SPECIMEN RETRIEVAL DEVICE TORE. THE BALLOON OF THE ACCESS BALLOON ALSO PHYSICALLY BROKE.

  Patient problems: Insufficient Information

  MAUDE report 15945418 ↗
• MalfunctionFeb 17, 2022Melted; Material Split, Cut or Torn; Melted; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER DURING LAPAROSCOPIC CHOLECYSTECTOMY, ON THE REMOVAL OF SPECIMEN, WHEN THE BAG WAS PULLED OUT OF THE INTRODUCER IT HAD HOLES AND LOOKED AS IF IT WAS MELTED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549231 ↗
• MalfunctionAug 10, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY OF A LAPAROSCOPIC CHOLECYSTECTOMY, WHILE BEING TESTED, THE 2 BAGS TORE. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12305238 ↗
• MalfunctionJun 7, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, AIR OR GAS LEAKED FROM THE SEAL. THE RETRIEVAL BAG ALSO TORE.

  Patient problems: Insufficient Information

  MAUDE report 11951558 ↗
• MalfunctionMay 24, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE BAG WAS BROKEN. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11873796 ↗
• MalfunctionApr 29, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE BAG WAS BROKEN. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11750581 ↗