Polysorb GL-303Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521045224), received between Apr 26, 2017 and Jun 11, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K963253, K981935); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THE SUTURES WERE USED TO CLOSE THE ABDOMINAL WALL DURING CASTRATION PROCEDURE PERFORMED UNDER GENERAL ANESTHESIA. POST-OPERATIVELY, THE SUTURE LINE DID NOT HOLD AND THE SEAMS OPENED UP AGAIN. FOLLOW-UP SURGERY WAS REQUIRED UNDER GENERAL ANESTHESIA, WITH REPEAT ABDOMINAL SUTURES.

  Patient problems: Tissue Breakdown

  MAUDE report 22185395 ↗
• MalfunctionJan 22, 2025Break; Break

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC INGUINAL HERNIA REPAIR, DURING PERITONEAL SUTURING, THE THREAD OF THREE SUTURES BROKE IN THE CENTER. SEVERAL NEW SUTURES FROM ANOTHER LOT WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21205082 ↗
• MalfunctionJan 22, 2025Break; Break

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC INGUINAL HERNIA REPAIR, DURING PERITONEAL SUTURING, THE THREAD OF THREE SUTURES BROKE IN THE CENTER. SEVERAL NEW SUTURES FROM ANOTHER LOT WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21205076 ↗
• MalfunctionJan 22, 2025Break; Break

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC INGUINAL HERNIA REPAIR, DURING PERITONEAL SUTURING, THE THREAD OF THREE SUTURES BROKE IN THE CENTER. SEVERAL NEW SUTURES FROM ANOTHER LOT WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21205071 ↗
• MalfunctionJul 24, 2023Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE PACKAGE WAS OPENED, THE NEEDLE HAD FALLEN INTO THE PACKAGE AND COULD NOT BE TAKEN OUT BECAUSE IT COULD NOT BE CLAMPED BY THE NEEDLE HOLDER. THE SAME THING HAPPENED IN THREE QUANTITIES CONSECUTIVELY, AND WITH THE FOURTH QUANTITY THE PRODUCT IN THE PACKAGE APPEARED.

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

  MAUDE report 17382072 ↗
• MalfunctionJul 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC COELIO RIGHT INGUINAL HERNIA PROCEDURE, THE NEEDLE WAS LOST WHEN THE THREAD WAS REMOVED THROUGH THE TROCAR. THE NEEDLE DETACHED FROM THE THREAD WHEN IT WAS WITHDRAWN THROUGH THE TROCAR. THE TEAM SEARCHED FOR THE NEEDLE DURING AND AFTER THE OPERATION BUT COULD NOT FIND IT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. IT WAS STATED THAT ANOTHER NEEDLE DETACHED FROM THE THREAD BEFOREHAND DURING THE OPERATION, BUT THE NEEDLE WAS NOT LOST. THE NEEDLE ALSO DID NOT FALL INTO THE PATIENT'S CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17259726 ↗
• MalfunctionJul 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC COELIO RIGHT INGUINAL HERNIA PROCEDURE, THE NEEDLE WAS LOST WHEN THE THREAD WAS REMOVED THROUGH THE TROCAR. THE NEEDLE DETACHED FROM THE THREAD WHEN IT WAS WITHDRAWN THROUGH THE TROCAR. THE TEAM SEARCHED FOR THE NEEDLE DURING AND AFTER THE OPERATION BUT COULD NOT FIND IT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. IT WAS STATED THAT ANOTHER NEEDLE DETACHED FROM THE THREAD BEFOREHAND DURING THE OPERATION, BUT THE NEEDLE WAS NOT LOST. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17259645 ↗
• MalfunctionSep 28, 2017Component Missing; Packaging Problem; Component Missing; Packaging Problem

  ACCORDING TO THE REPORTER, THE PRODUCT'S NEEDLE WAS NOT IN THE NEEDLE HOLDER AS IT SHOULD BE. THE NEEDLE COULD NOT BE TAKEN OUT IMMEDIATELY IT WAS HIDDEN IN A PLASTIC ENCLOSURE. TO TAKE THE NEEDLE OUT, ONE HAS TO OPEN THE PLASTIC ENCLOSURE. ACCORDINGLY, IT WAS DISTURBING FOR A COMPLICATED SURGERY. PATIENT INVOLVEMENT WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6900239 ↗
• MalfunctionApr 26, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING THE PROCEDURE, BUT WAS NOT USED ON THE PATIENT. WHEN THE SURGEON GRASPED THE NEEDLE AND ATTEMPTED TO REMOVE THE SUTURE FROM THE PACKAGING; HE NOTICED IT WAS SEPARATED FROM THE SUTURE THREAD. TO COMPLETE THE PROCEDURE, ANOTHER DEVICE WAS USED. NO PATIENT INJURY OR EXTENSION IN SURGICAL TIME. PATIENT STATUS IS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6523824 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963253, K981935. One submission often covers many models, so check the product and lot details in each record.

• Z-2601-2018 · Jun 15, 2018 · Terminated
  Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
• Z-2541-2017 · May 3, 2017 · Terminated
  Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VI