Polysorb GL-124Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884521044982), received between Apr 13, 2021 and Apr 10, 2026 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (10 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. 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LEFT UPPER LUNG LOBECTOMY WITH ROBOTIC MEDIASTINAL LYMPH NODE DISSECTION, AT THE END OF THE PROCEDURE, THE THREE SUTURES FROM THE SAME BOX HAD NEEDLE DETACHMENT. THE THREAD WAS CHANGED THREE TIMES TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24843114 ↗
• MalfunctionApr 10, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LEFT UPPER LUNG LOBECTOMY WITH ROBOTIC MEDIASTINAL LYMPH NODE DISSECTION, AT THE END OF THE PROCEDURE, THE THREE SUTURES FROM THE SAME BOX HAD NEEDLE DETACHMENT. THE THREAD WAS CHANGED THREE TIMES TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24843054 ↗
• MalfunctionApr 10, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SURGERY, AT THE END OF THE PROCEDURE, THE THREE SUTURES FROM THE SAME BOX HAD NEEDLE DETACHMENT. THE THREAD WAS CHANGED THREE TIMES TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24838426 ↗
• MalfunctionJul 11, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING THE TOTAL LAPAROSCOPIC HYSTERECTOMY, WHEN THE SURGEON WAS SUTURING THE VAGINAL VAULT, THE SUTURE BROKE MID STRAND MAKING TYING THE SUTURE VERY DIFFICULT. THERE WAS AN ADDITIONAL TIME BUT NOT FOR MORE THAN 30 MINUTES. A NEW SUTURE WAS OPENED TO CLOSE THE VAULT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22487651 ↗
• InjuryMar 17, 2025Device Slipped; Use of Device Problem; Device Slipped; Use of Device Problem

  IT WAS REPORTED THAT DURING A TOTAL LARYNGECTOMY PLUS EMPTYING, IN RECONSTRUCTION OF TISSUES, THE LAST KNOTS OF THE SUTURE WERE FOUND TO BE LOOSE, NECESSITATING REPEATED STITCHES AND CAUSING TISSUE INJURY. TWENTY-FOUR HOURS POSTOPERATIVELY, AN EPISODE OF BLEEDING OCCURRED, PROMPTING A REVIEW OF THE HEMOSTATIC SURGICAL SITE BY THE OTOLARYNGOLOGIST. LOOSE POLYSORB SUTURE STITCHES WERE IDENTIFIED, THERE WAS INCREASED DIFFUSE BLEEDING FROM THE SURGICAL SITE, WHICH REQUIRED SURGICAL REVISION, AND INCREASED SALIVARY FISTULAS WERE OBSERVED IN THE POST-SURGICAL PERIOD.

  Patient problems: Fistula; Hemorrhage/Blood Loss/Bleeding; Laceration(s); Tissue Breakdown

  MAUDE report 21626793 ↗
• MalfunctionNov 18, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE SUTURE MATERIAL WAS TO BE USED FOR A BREAST OPERATION. HOWEVER, IT IMMEDIATELY BECAME APPARENT THAT THE NEEDLES WERE BROKEN UPON OPENING THE PACKAGE. THE NEEDLES THEREFORE WERE NOT USED. IT WAS NOTED THAT THE ENTIRE PACKAGE WAS AFFECTED. A NEW PACK WAS THEREFORE TAKEN AND THE OPERATION CONTINUED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20707019 ↗
• MalfunctionNov 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN EVENTRATION INGUINAL HERNIA PROCEDURE, THREE NEEDLES DETACHED. THE THREAD SEPARATED FROM THE NEEDLE BOTH WHEN REMOVING IT FROM THE PACKAGE AND WHEN SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20623332 ↗
• MalfunctionNov 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN EVENTRATION INGUINAL HERNIA PROCEDURE, THREE NEEDLES DETACHED. THE THREAD SEPARATED FROM THE NEEDLE BOTH WHEN REMOVING IT FROM THE PACKAGE AND WHEN SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20623143 ↗
• MalfunctionNov 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN EVENTRATION INGUINAL HERNIA PROCEDURE, THREE NEEDLES DETACHED. THE THREAD SEPARATED FROM THE NEEDLE BOTH WHEN REMOVING IT FROM THE PACKAGE AND WHEN SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622619 ↗
• InjuryMay 17, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROSTATECTOMY, THE NEEDLE BROKE AND PART OF THE NEEDLE FELL INTO THE CAVITY OF THE PATIENT. THE PART OF THE NEEDLE THAT FELL INTO CAVITY WAS NOT FOUND AND REMAINED IN PATIENT'S CAVITY. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. NO FURTHER TREATMENT WAS PLANNED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19345751 ↗
• MalfunctionFeb 22, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC CHOLECYSTECTOMY, WHILE SUTURING MANUALLY WHEN PERFORMING SYNTHESIS OF THE APONEUROTIC PLANE OF T1, THE NEEDLE BROKE. A PART OF THE NEEDLE FELL INTO THE CAVITY. THE SURGEON HAD TO EXTEND THE INCISION OF THE T2 PORT TO LOOK FOR THE NEEDLE¿S METALLIC FRAGMENTS AND EXTRACT IT WITH LAPAROSCOPIC FORCEPS. THE BROKEN NEEDLE WAS REMOVED. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 25 MINUTES DUE TO THE PRODUCT PROBLEM. ANOTHER DEVICE FROM ANOTHER LOT WAS USED TO COMPLETE THE CASE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16423962 ↗
• MalfunctionOct 26, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING FOOT SURGERY, THE FIVE NEEDLES BROKE OFF. SAME PRODUCT WITH ANOTHER LOT NUMBER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15673478 ↗
• MalfunctionFeb 25, 2022Break; Break

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC PROCEDURE, WHILE CLOSING DEEP LAYER OF STOMACH WALL OF A PORT INCISION, THE THREAD BROKE AND THE SUTURE STRIPPED. TO RESOLVE THE ISSUE, THE SURGEON OPENED A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13599908 ↗
• MalfunctionApr 13, 2021Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE NEEDLE SNAPPED INTO THREE PIECES WHILE TYING SUTURE IN VAGINAL VAULT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11656896 ↗
• MalfunctionApr 13, 2021Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE NEEDLE SNAPPED INTO THREE PIECES WHILE TYING SUTURE IN VAGINAL VAULT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11656890 ↗
• MalfunctionApr 13, 2021Break; Break

  ACCORDING TO THE REPORTER, THE NEEDLE OF THE SUTURE SNAPPED INTO THREE PIECES WHILE TYING IN THE VAGINAL VAULT. THE THREE KNOTS WERE INTACT, AND THE SUTURE WAS BROKEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11656859 ↗
• MalfunctionApr 13, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING VAULT CLOSURE AT TOTAL LAPAROSCOPIC HYSTERECTOMY, THE SURGEON WAS PERFORMING THE EXTRACORPORAL ROTAR KNOT WHICH WAS A SINGLE KNOT TIED OUTSIDE THE BODY AND THEN SECURED WITH A KNOT PUSHER. THE THREE KNOTS WERE INTACT AND THE SUTURE WAS BROKEN. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11656823 ↗

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