Polysorb GL-181Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10884521045057), received between Apr 10, 2019 and Sep 19, 2026 — classified as 5 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (21 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 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2026Unraveled Material

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50831870 ↗
• MalfunctionSep 17, 2026Unraveled Material

  According to the reporter, the patient delivered on (b)(6) 2026 and had a first-degree perineal laceration. On August 16, the patient returned for evaluation and found that all superficial sutures had detached, with the exposed suture material being relatively hard. A regular follow-up and disinfection were required.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50802031 ↗
• MalfunctionAug 28, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50493696 ↗
• MalfunctionJul 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DENTAL IMPLANT PLACEMENT PROCEDURE, WHILE SUTURING GUM TISSUE USING A CONTINUOUS SUTURING TECHNIQUE, BOTH THE NEEDLE AND THE SUTURE THREAD BROKE AFTER THE 5TH¿6TH STITCH. THE SUTURE HAD BEEN TREATED WITH NORMAL SALINE PRIOR TO USE AND WAS USED IMMEDIATELY AFTER BEING OPENED. TO RESOLVE THE ISSUE, THE CLINICIAN REPLACED THE SUTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25677659 ↗
• MalfunctionJun 4, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SURGERY, AFTER ROUTINE NEEDLE INSERTION, ONLY THE SUTURE WAS VISIBLE IN THE LAPAROSCOPIC FIELD AND THE NEEDLE WAS MISSING. THE SURGICAL TEAM CONDUCTED AN INTRAOPERATIVE SEARCH OF THE ABDOMINAL CAVITY AND OPERATING TABLE BUT COULD NOT LOCATE IT. STAFF OUTSIDE THE STERILE FIELD ASSISTED USING A NEEDLE FINDER, AND THE NEEDLE WAS FOUND AFTER APPROXIMATELY TEN MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25402600 ↗
• MalfunctionApr 28, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC LOBECTOMY, WHEN THE SCRUB NURSE GRASPED THE NEEDLE WITH A NEEDLE HOLDER AND PULLED THE SUTURE FROM THE PACKAGE, DETACHMENT OCCURRED BETWEEN THE NEEDLE AND THE SUTURE AT THE NEEDLE END. THE NURSE THEN TOOK ANOTHER SUTURE FROM THE SAME PACKAGE AND PASSED IT TO THE PHYSICIAN; NO DETACHMENT OCCURRED AT THIS TIME. HOWEVER, DURING SKIN CLOSURE, WHEN THE PHYSICIAN GRASPED THE NEEDLE WITH A NEEDLE HOLDER AND APPLIED TRACTION TO THE SUTURE, DETACHMENT BETWEEN THE NEEDLE AND THE SUTURE OCCURRED AGAIN AT THE SAME LOCATION. ULTIMATELY, THE PHYSICIAN SELECTED A CONVENTIONAL SILK SUTURE TO COMPLETE INCISION CLOSURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25016256 ↗
• MalfunctionApr 28, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC LOBECTOMY, WHEN THE SCRUB NURSE GRASPED THE NEEDLE WITH A NEEDLE HOLDER AND PULLED THE SUTURE FROM THE PACKAGE, DETACHMENT OCCURRED BETWEEN THE NEEDLE AND THE SUTURE AT THE NEEDLE END. THE NURSE THEN TOOK ANOTHER SUTURE FROM THE SAME PACKAGE AND PASSED IT TO THE PHYSICIAN; NO DETACHMENT OCCURRED AT THIS TIME. HOWEVER, DURING SKIN CLOSURE, WHEN THE PHYSICIAN GRASPED THE NEEDLE WITH A NEEDLE HOLDER AND APPLIED TRACTION TO THE SUTURE, DETACHMENT BETWEEN THE NEEDLE AND THE SUTURE OCCURRED AGAIN AT THE SAME LOCATION. ULTIMATELY, THE PHYSICIAN SELECTED A CONVENTIONAL SILK SUTURE TO COMPLETE INCISION CLOSURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25016253 ↗
• MalfunctionApr 16, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A GASTROINTESTINAL SURGERY, THE NEEDLE DETACHED UPON PLACEMENT OF THE FIRST STITCH. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896921 ↗
• MalfunctionJan 16, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SEVEN DAYS AFTER AN EPISIOTOMY PROCEDURE, IT WAS FOUND THAT SOME OF THE SUTURES AT THE EPISIOTOMY SITE HAD NOT BEEN ABSORBED, AND THE WOUND SHOWED POOR HEALING. THE PATIENT WAS INSTRUCTED TO PERFORM REGULAR DISINFECTION, USE MEDICATIONS TO PROMOTE WOUND HEALING, AND ATTEND FOLLOW-UP VISITS AS SCHEDULED.

  Patient problems: Impaired Healing

  MAUDE report 24102847 ↗
• MalfunctionDec 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, ON (B)(6), THE SUTURE WAS USED DURING SURGERY. THE PATIENT WAS DISCHARGED ON (B)(6) WITH A SMALL AMOUNT OF EXUDATE AT THE WOUND SITE. MULTIPLE FOLLOW-UP VISITS TO THE HOSPITAL SHOWED NO IMPROVEMENT. ON (B)(6), DURING ANOTHER FOLLOW-UP, A PORTION OF THE EXTERNAL SUTURE WAS REMOVED. A SUTURE REACTION WAS CONSIDERED AFTER IMPLANTATION, LIKELY DUE TO SUTURE REJECTION, WHICH RESULTED IN SLOW ABSORPTION. ALTHOUGH PART OF THE EXTERNAL SUTURE WAS REMOVED, THE DEEP SUTURE COULD NOT BE EXTRACTED. PURULENT DISCHARGE AND SCABBING, ALONG WITH SUBCUTANEOUS PUS ACCUMULATION, WERE OBSERVED ON THE RIGHT INDEX AND RING FINGERS. WOUND HEALING WAS POOR, AND THE SUTURE REMAINED UNABSORBED FOR MORE THAN ONE MONTH.

  Patient problems: Abscess; Purulent Discharge

  MAUDE report 23827607 ↗
• MalfunctionNov 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A PROCEDURE, THE THREAD OF THE DEVICE BROKE AS SOON AS IT WAS OPENED. THIS ISSUE OCCURRED ON THREE DEVICES. ADDITIONALLY ON THE FOURTH DEVICE, THE NEEDLE AND THREAD BROKE WHILE BEING USED.

  Patient problems: Insufficient Information

  MAUDE report 23539955 ↗
• MalfunctionNov 12, 2025Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 12 DAYS AFTER A DELIVERY TO A LIVE BABY UNDER THE LATERAL INCISION, IT WAS FOUND THAT SOME SUTURES IN THE SIDE INCISION WERE NOT ABSORBED AND THE WOUND HEALED POORLY. THE PATIENT WAS ADVISED TO DISINFECT THE WOUND ON TIME AND KEEP IT CLEAN AND DRY, USED MEDICATIONS THAT PROMOTE WOUND HEALING AND ATTEND REGULAR FOLLOW-UP VISITS.

  Patient problems: Impaired Healing; Unspecified Tissue Injury

  MAUDE report 23530760 ↗
• MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, IN SKIN CLOSURE, THE NEEDLE AND THREAD SEPARATED AT THE CONNECTION POINT AS THE NEEDLE TIP PASSED THROUGH THE TISSUE AND WAS ABOUT TO EXIT. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED.

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

  MAUDE report 23487685 ↗
• MalfunctionNov 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC OVARIAN CYSTECTOMY, ON THE SKIN, THE THREAD BROKE AS SOON AS IT WAS OPENED FOR USE. THIS ISSUE OCCURRED ON THREE DEVICES. ADDITIONALLY, WHILE USING A NEW DIFFERENT TYPE OF SUTURE ON THE FALLOPIAN TUBE, BOTH NEEDLE AND THREAD BROKE. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 23477208 ↗
• MalfunctionOct 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION, WHILE THE SURGEON WAS USING A SYNTHETIC ABSORBABLE SURGICAL SUTURE FOR SKIN CLOSURE, THE NEEDLE AND THREAD BECAME DETACHED AT THE CONNECTION POINT AS THE NEEDLE TIP PASSED THROUGH THE TISSUE AND WAS ABOUT TO EXIT. A NEW SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23443604 ↗
• MalfunctionSep 18, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AT THE TIME OF CLOSURE OF THE INCISION, THE ABSORBABLE SUTURE BROKE. THE SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089334 ↗
• MalfunctionJul 18, 2025Product Quality Problem; Component Missing; Product Quality Problem; Component Missing

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GYNECOLOGICAL HYSTERECTOMY, WHEN THE NURSE UNPACKED THE PACKAGE TO REMOVE THE SUTURE, THERE WAS ONLY THE SUTURE BUT NO NEEDLE, AND BY COMPARISON, IT WAS FOUND THAT THE LENGTH OF THE SUTURE REMOVED WAS DIFFERENT. THE USER REPLACED THE SUTURE TO CLOSE THE INCISION. THERE WAS AN INCREASE IN THE OPERATION TIME OF 30 MINUTES OR MORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22546527 ↗
• MalfunctionJan 9, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE SUTURE BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21115105 ↗
• MalfunctionNov 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A THYROID AND BREAST SURGERY, THE SUTURE HAD THE SITUATION THAT THE NEEDLE AND THREAD WERE DETACHED. IT WAS IMMEDIATELY REPLACED AND THE OPERATION WAS SUCCESSFULLY COMPLETED.

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

  MAUDE report 20683192 ↗
• MalfunctionNov 5, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, 35 DAYS POSTOPERATIVELY, WHEN THE SUTURE WAS REMOVED, THE SURGEON FOUND THAT THE SUTURE WAS NOT ABSORBED AND THE WOUND WAS RED, SWOLLEN, AND PUS-FILLED. A DISINFECTION AND DRESSING WERE IMMEDIATELY CARRIED OUT.

  Patient problems: Foreign Body Reaction; Purulent Discharge; Swelling/ Edema

  MAUDE report 20615744 ↗
• InjuryAug 21, 2024Unraveled Material; Patient-Device Incompatibility; Unraveled Material; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, FOLLOWING A CAESARIAN SECTION, THE PATIENT CAME FOR A FOLLOW-UP EXAMINATION, AND IT WAS FOUND THAT THE THREAD THAT WAS USED TO SUTURE THE INCISION WAS BROKEN, CAUSING THE INCISION TO SPLIT AND EXUDE FLUID. THE SKIN REJECTED THE SUTURE, AND IT AFFECTED THE WOUND HEALING. THE SUTURE WAS REPLACED, AND MEDICATION WAS CHANGED FOR FURTHER OBSERVATION.

  Patient problems: Fluid Discharge; Impaired Healing

  MAUDE report 20010578 ↗
• MalfunctionAug 13, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING SUTURING THE WOUND, THE SUTURE BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19975613 ↗
• MalfunctionJun 19, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE DOCTOR WAS SUTURING THE WOUND OF THE PATIENT, THE SUTURE SUDDENLY BROKE, CAUSING THE PROCEDURE TO BE INTERRUPTED AND THE SUTURE MOUTH TO BLEED. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19571025 ↗
• MalfunctionApr 26, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PREOPERATIVELY, LAPAROSCOPIC CHOLECYSTECTOMY, THE NURSES CHECKED THE SURGICAL SUPPLIES AND FOUND A SINGLE ABSORBABLE SUTURE; THERE WERE EXTRA NEEDLES IN THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19193641 ↗
• MalfunctionJan 31, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A GASTROINTESTINAL SURGERY, WHEN PERFORMING ANAL FISSURE RESECTION, WHEN THE DOCTOR PULLED OUT THE SUTURE DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. THIS HAPPENED TWICE DURING THE PROCEDURE. A 3RD SUTURE WAS THEN USED WHICH RESOLVED THE ISSUE. THE SURGICAL TIME WAS INCREASED DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18618887 ↗

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