Polysorb GLS-323Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521045668), received between Oct 8, 2018 and Feb 18, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR COLPORRHAPHY RECTOCELE REPAIR AND PELVIC FLOOR PROSTHESIS LAPAROSCOPIC PROCEDURE, THREE OF THE STRINGS POPPED OFF THE NEEDLE. THE TIP OF NEEDLE BROKE OFF THE PATIENT IN ONE AND WAS NOT FOUND. NO IMAGING WAS USED TO LOCATE THE LOST NEEDLE TIP. DUE TO THE NEEDLE BREAKAGE, AN INCREASED NUMBER OF SUTURES WAS REQUIRED TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24384570 ↗
• MalfunctionFeb 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANTERIOR COLPORRHAPHY RECTOCELE REPAIR AND PELVIC FLOOR PROSTHESIS LAPAROSCOPIC PROCEDURE, THREE OF THE STRINGS POPPED OFF THE NEEDLE. THE TIP OF NEEDLE BROKE OFF THE PATIENT IN ONE AND WAS NOT FOUND. NO IMAGING WAS USED TO LOCATE THE LOST NEEDLE TIP. DUE TO THE NEEDLE BREAKAGE, AN INCREASED NUMBER OF SUTURES WAS REQUIRED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384565 ↗
• MalfunctionFeb 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANTERIOR COLPORRHAPHY RECTOCELE REPAIR AND PELVIC FLOOR PROSTHESIS LAPAROSCOPIC PROCEDURE, THREE OF THE STRINGS POPPED OFF THE NEEDLE. THE TIP OF NEEDLE BROKE OFF THE PATIENT IN ONE AND WAS NOT FOUND. NO IMAGING WAS USED TO LOCATE THE LOST NEEDLE TIP. DUE TO THE NEEDLE BREAKAGE, AN INCREASED NUMBER OF SUTURES WAS REQUIRED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384558 ↗
• MalfunctionFeb 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANTERIOR COLPORRHAPHY RECTOCELE REPAIR AND PELVIC FLOOR PROSTHESIS LAPAROSCOPIC PROCEDURE, THREE OF THE STRINGS POPPED OFF THE NEEDLE. THE TIP OF NEEDLE BROKE OFF THE PATIENT IN ONE AND WAS NOT FOUND. NO IMAGING WAS USED TO LOCATE THE LOST NEEDLE TIP. DUE TO THE NEEDLE BREAKAGE, AN INCREASED NUMBER OF SUTURES WAS REQUIRED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384535 ↗
• MalfunctionFeb 14, 2026Break

  IT WAS REPORTED THAT PRIOR TO USE, THE NEEDLE TIP BROKE OFF IN THE PACKAGING AND WAS FOUND IN SALINE LATER ON. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24340461 ↗
• MalfunctionMar 21, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A ROBOTIC ASSISTED HYSTERECTOMY, THE THREAD OF THE SUTURE BROKE AFTER THE CASE, AND THE OTHER NEEDLE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21661629 ↗
• MalfunctionFeb 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN CORONARY BYPASS GRAFT SURGERY, THE NEEDLE POPPED OFF THE SWAGE ON TWO CONSECUTIVE SUTURES. THE THIRD SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18744719 ↗
• MalfunctionFeb 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN CORONARY BYPASS GRAFT SURGERY, THE NEEDLE POPPED OFF THE SWAGE ON TWO CONSECUTIVE SUTURES. THE THIRD SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18744711 ↗
• MalfunctionJul 11, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TIP OF THE SUTURE BROKE OFF TWICE.

  Patient problems: Insufficient Information

  MAUDE report 14982502 ↗
• MalfunctionJun 10, 2022Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE TIP OF THE NEEDLE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 14657500 ↗
• MalfunctionNov 23, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, 30 DAYS POSTOPERATIVE TO OPEN RIGHT TOTAL REVERSE ARTHROPLASTY, THE SURGEON PULLED OUT REMNANT SUTURE THAT WAS STICKING STRAIGHT OUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865442 ↗
• MalfunctionOct 8, 2018Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING AN OPEN EXPLORATORY LAPAROTOMY, TWO OF THESE SUTURES UNRAVELED AFTER SEWING. THEY OPENED NEW SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7942867 ↗

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