Polysorb GL-182Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 10884521045064), received between Aug 31, 2017 and Jun 17, 2026 — classified as 24 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Break” (46 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 96 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, A PATIENT UNDERWENT VAGINAL DELIVERY WITH PERINEAL PROTECTION AND DURING WHICH A FIRST-DEGREE PERINEAL LACERATION OCCURRED AND WAS SUTURED USING AN ABSORBABLE SURGICAL SUTURE. DURING A FOLLOW-UP VISIT TO THE OBSTETRICS OUTPATIENT CLINIC, THE PATIENT REPORTED PAIN AT THE INCISION SITE, AND EXAMINATION REVEALED THAT THE SUTURE HAD NOT BEEN ABSORBED. THE SUTURE WAS REMOVED IMMEDIATELY, AND THE PATIENT SUBSEQUENTLY REPORTED NO FURTHER PAIN AT THE INCISION SITE.

  Patient problems: Pain

  MAUDE report 25538212 ↗
• InjuryAug 22, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, DURING A BILATERAL BREAST TUMOR RESECTION, THE SURGICAL WOUND WAS CLOSED USING THE SYNTHETIC ABSORBABLE SUTURE. AFTER DISCHARGE, A MONTH AFTER THE INITIAL PROCEDURE THE WOUND WAS FOUND TO BE SUPPURATING, INFECTED, AND NOT HEALING. THE SURGEON PERFORMED A SECONDARY WOUND CLOSURE PROCEDURE, AFTER WHICH THE SYMPTOMS IMPROVED.

  Patient problems: Impaired Healing; Post Operative Wound Infection; Purulent Discharge; Tissue Breakdown

  MAUDE report 22877198 ↗
• InjuryMar 28, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVELY OF A DIGESTIVE SURGERY, THE KNOT OF THE SUTURE LOOSENED FOR NO PHYSICAL REASON. THE ISSUE HAS RESULTED IN DEHISCENCE. ANOTHER SUTURE WAS USED.

  Patient problems: Wound Dehiscence

  MAUDE report 21726768 ↗
• MalfunctionFeb 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, A SUTURE WAS USED AFTER A PATIENT'S DELIVERY OF A BABY BOY WITH A LEFT EPISIOTOMY, AND AFTER A MONTH, THE PATIENT COMPLAINED OF INCISION PAIN. IT WAS FOUND THAT THE SUTURE WAS NOT ABSORBED. THE SUTURE WAS IMMEDIATELY REMOVED TO RESOLVE THE ISSUE.

  Patient problems: Pain

  MAUDE report 21362090 ↗
• MalfunctionJan 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY TO LEFT EPISIOTOMY DURING NORMAL DELIVERY, SYNTHETIC ABSORBABLE SURGICAL SUTURE WAS ROUTINELY USED FOR INTRADERMAL SUTURE. WHILE SUTURING, THE SUTURE WAS SEPARATED FROM THE NEEDLE TAIL. TO RESOLVE THE ISSUE, THE MIDWIFE QUICKLY WITHDREW THE BROKEN NEEDLE AND REPLACED IT WITH A NEW SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207674 ↗
• MalfunctionDec 4, 2024Break; Detachment of Device or Device Component; Material Twisted/Bent; Break; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SUTURE, THE THREAD DISCONNECTED FROM THE NEEDLE WHILE THE NEEDLE WAS INSIDE THE WOUND. ADDITIONALLY, THE STITCH WAS DESCRIBED AS FRAGILE, AND THE NEEDLE WAS BENT EASILY. IT OCCURRED ON 13 SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 20844482 ↗
• MalfunctionDec 4, 2024Break; Detachment of Device or Device Component; Material Twisted/Bent; Break; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SUTURE, THE THREAD DISCONNECTED FROM THE NEEDLE WHILE THE NEEDLE WAS INSIDE THE WOUND. ADDITIONALLY, THE STITCH WAS DESCRIBED AS FRAGILE, AND THE NEEDLE WAS BENT EASILY. IT OCCURRED ON 13 SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 20844228 ↗
• MalfunctionDec 4, 2024Break; Detachment of Device or Device Component; Material Twisted/Bent; Break; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SUTURE, THE THREAD DISCONNECTED FROM THE NEEDLE WHILE THE NEEDLE WAS INSIDE THE WOUND. ADDITIONALLY, THE STITCH WAS DESCRIBED AS FRAGILE, AND THE NEEDLE WAS BENT EASILY. IT OCCURRED ON 13 SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 20844155 ↗
• MalfunctionDec 4, 2024Break; Detachment of Device or Device Component; Material Twisted/Bent; Break; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SUTURE, THE THREAD DISCONNECTED FROM THE NEEDLE WHILE THE NEEDLE WAS INSIDE THE WOUND. ADDITIONALLY, THE STITCH WAS DESCRIBED AS FRAGILE, AND THE NEEDLE BENT EASILY. IT OCCURRED ON 13 SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 20843797 ↗
• MalfunctionDec 4, 2024Break; Detachment of Device or Device Component; Material Twisted/Bent; Break; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SUTURE, THE THREAD DISCONNECTED FROM THE NEEDLE WHILE THE NEEDLE WAS INSIDE THE WOUND. ADDITIONALLY, THE STITCH WAS DESCRIBED AS FRAGILE, AND THE NEEDLE BENT EASILY. IT OCCURRED ON 13 SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 20843679 ↗
• MalfunctionDec 4, 2024Break; Detachment of Device or Device Component; Material Twisted/Bent; Break; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SUTURE, THE THREAD DISCONNECTED FROM THE NEEDLE WHILE THE NEEDLE WAS INSIDE THE WOUND. ADDITIONALLY, THE STITCH WAS DESCRIBED AS FRAGILE, AND THE NEEDLE BENT EASILY. IT OCCURRED ON 13 SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 20843670 ↗
• MalfunctionDec 4, 2024Break; Detachment of Device or Device Component; Material Twisted/Bent; Break; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SUTURE, THE THREAD DISCONNECTED FROM THE NEEDLE WHILE THE NEEDLE WAS INSIDE THE WOUND. ADDITIONALLY, THE STITCH WAS DESCRIBED AS FRAGILE, AND THE NEEDLE BENT EASILY. IT OCCURRED ON 13 SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 20843633 ↗
• MalfunctionDec 4, 2024Break; Detachment of Device or Device Component; Material Twisted/Bent; Break; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SUTURE, THE THREAD DISCONNECTED FROM THE NEEDLE WHILE THE NEEDLE WAS INSIDE THE WOUND. ADDITIONALLY, THE STITCH WAS DESCRIBED AS FRAGILE, AND THE NEEDLE BENT EASILY. IT OCCURRED ON 13 SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 20843613 ↗
• MalfunctionDec 4, 2024Break; Detachment of Device or Device Component; Material Twisted/Bent; Break; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SUTURE, THE THREAD DISCONNECTED FROM THE NEEDLE WHILE THE NEEDLE WAS INSIDE THE WOUND. ADDITIONALLY, THE STITCH WAS DESCRIBED AS FRAGILE, AND THE NEEDLE BENT EASILY. IT OCCURRED ON 13 SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 20843554 ↗
• MalfunctionDec 4, 2024Break; Detachment of Device or Device Component; Material Twisted/Bent; Break; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SUTURE, THE THREAD DISCONNECTED FROM THE NEEDLE WHILE THE NEEDLE WAS INSIDE THE WOUND. ADDITIONALLY, THE STITCH WAS DESCRIBED AS FRAGILE, AND THE NEEDLE BENT EASILY. IT OCCURRED ON 13 SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 20843425 ↗
• MalfunctionDec 4, 2024Break; Detachment of Device or Device Component; Material Twisted/Bent; Break; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SUTURE, THE THREAD DISCONNECTED FROM THE NEEDLE WHILE THE NEEDLE WAS INSIDE THE WOUND. ADDITIONALLY, THE STITCH WAS DESCRIBED AS FRAGILE, AND THE NEEDLE BENT EASILY. IT OCCURRED ON 13 SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 20843416 ↗
• MalfunctionDec 4, 2024Break; Detachment of Device or Device Component; Material Twisted/Bent; Break; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SUTURE, THE THREAD DISCONNECTED FROM THE NEEDLE WHILE THE NEEDLE WAS INSIDE THE WOUND. ADDITIONALLY, THE STITCH WAS DESCRIBED AS FRAGILE, AND THE NEEDLE BENT EASILY. IT OCCURRED ON 13 SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 20842923 ↗
• MalfunctionDec 4, 2024Break; Detachment of Device or Device Component; Material Twisted/Bent; Break; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SUTURE, THE THREAD DISCONNECTED FROM THE NEEDLE WHILE THE NEEDLE WAS INSIDE THE WOUND. ADDITIONALLY, THE STITCH WAS DESCRIBED AS FRAGILE, AND THE NEEDLE BENT EASILY. IT OCCURRED ON 13 SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 20842846 ↗
• MalfunctionNov 20, 2024Unraveled Material; Patient-Device Incompatibility; Unraveled Material; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, 28 DAYS AFTER A CESAREAN SECTION, THE PATIENT RETURNED TO THE HOSPITAL FOR A FOLLOW-UP DUE TO BLOODY EXUDATION FROM THE ABDOMINAL INCISION. UPON CHECKING, UNDEGRADED FREE SUTURES COULD BE SEEN TWO CENTIMETERS (CM) TO THE RIGHT OF THE INCISION. THE SURGICAL INCISION CRACK, THE WOUND HEALING WAS DELAYED AND CAUSED WOUND INFECTION. THE INCISION WAS SPLIT IN ONE CM, AND THE BOTTOM REACHED THE SUBCUTANEOUS FAT LAYER. THE UNDEGRADED SUTURE WAS REMOVED FROM THE INCISION. NO PURULENT SECRETIONS WERE SEEN FROM THE INCISION. THE PATIENT WAS REGULARLY CHANGED FOR DRESSING AND GIVEN A WOUND HEALING SPRAY FOR EXTERNAL USE TO PROMOTE WOUND HEALING. THE PATIENT WAS REVISITED THREE DAYS LATER AND REPORTED THAT THE WOUND HAD HEALED.

  Patient problems: Post Operative Wound Infection; Purulent Discharge; Wound Dehiscence

  MAUDE report 20740478 ↗
• InjuryNov 15, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, 4 DAYS POSTOPERATIVELY OF WOUND SUTURING, THE PATIENT COMPLAINED OF SKIN ITCHING, DISCOMFORT, AND PAIN AT THE WOUND. OBSERVATION REVEALED THAT THE SUTURE WAS POORLY ABSORBED, AND REDNESS SWELLING AND SUPPURATION WERE OBSERVED AT THE SITE WHERE THE SUTURE PASSED THROUGH. THE PATIENT FELT PAIN WHEN IT WAS PRESSED. THE UNABSORBED SUTURE WAS CUT OPEN, AND THE WOUND WAS DISINFECTED, PUS WAS DRAINED, AND DRESSINGS WERE CHANGED EVERY DAY. ORAL ANTIBIOTICS AND ANTIHISTAMINES WERE GIVEN FOR SYMPTOMATIC SUPPORTIVE TREATMENT. AFTER TREATMENT, THE ADVERSE REACTION SYMPTOM GRADUALLY IMPROVED.

  Patient problems: Discomfort; Itching Sensation; Pain; Purulent Discharge; Skin Inflammation/ Irritation

  MAUDE report 20694605 ↗
• MalfunctionNov 13, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, THE DOCTOR USED THE SYNTHETIC ABSORBABLE SURGICAL SUTURE TO SUTURE THE PATIENT'S WOUND UNDER LOCAL ANESTHESIA, AND THE SUTURE AND BANDAGE WERE COMPLETED, FOUR HOURS POSTOPERATIVELY, THE PATIENT CAME TO THE HOSPITAL AGAIN AND REPORTED THAT THE WOUND WAS PAINFUL AND THE WOUND DRESSING HAS OOZED BLOOD. AFTER EXAMINATION, THE DOCTOR FOUND THAT THE WOUND HAD SPLIT, BLOOD WAS OOZING, AND THE SYNTHETIC ABSORBABLE SURGICAL SUTURE HAD BROKEN. THE DOCTOR IMMEDIATELY USED MEDICAL ALCOHOL TO DISINFECT THE PATIENT'S WOUND AND RE-SUTURED THE PATIENT'S WOUND. AFTER THE SUTURE WAS COMPLETED, THE WOUND WAS BANDAGED, AND THE PATIENT WAS KEPT FOR OBSERVATION AND GIVEN ANTI-INFLAMMATORY AND HEMOSTATIC TREATMENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 20671788 ↗
• MalfunctionNov 8, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER OPENING THE PACKAGE, IT WAS FOUND THAT THE NEEDLE WAS BROKEN AND COULD NOT BE USED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20637206 ↗
• InjuryOct 30, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE A LAPAROSCOPIC CHOLECYSTECTOMY, COMMON BILE DUCT INCISION AND LITHOTOMY, AND T-TUBE DRAINAGE, THE SURGICAL INCISION WAS SUTURED AND BANDAGED WITH A CLEAN DRESSING BLOCK AND FIXED WITH A PRESSURE-SENSITIVE ADHESIVE TAPE. THE FOLLOWING DAY THE PATIENT'S SKIN AT THE SUTURE SITE WAS RED, SWOLLEN, ITCHY AND UNCOMFORTABLE. THE SUTURES WERE THEN REMOVED. AFTER THE RED, SWOLLEN AND ITCHY AREAS WERE SCRUBBED WITH IODINE COTTON BALLS, THE WOUND WAS STUFFED WITH STERILE GAUZE. ON THE 3RD DAY THE ITCHING AND RASH WERE SIGNIFICANTLY RELIEVED.

  Patient problems: Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 20566707 ↗
• MalfunctionOct 29, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING LABOR AND DELIVERY, WHEN SUTURING THE PERINEUM, THE NEEDLE AND SUTURE BROKE DURING CONTINUOUS STITCHING. THE SURGEON USED A FORCEPS TO REMOVE THE BROKEN NEEDLE. A NEW SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20563714 ↗
• MalfunctionOct 21, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, THE PATIENT WAS GIVEN A SYNTHETIC ABSORBABLE SURGICAL SUTURE TO SUTURE THE EPISIOTOMY DUE TO VAGINAL DELIVERY OF A FULL-TERM MATURE LIVE MALE BABY UNDER EPISIOTOMY. THE AFFECTED AREA OF THE EPISIOTOMY SUTURES EXPERIENCED STINGING PAIN, REDNESS, SWELLING, AND ITCHING. THE PATIENT WAS ALLERGIC TO SYNTHETIC ABSORBABLE SURGICAL SUTURES. THE PATIENT WAS ADVISED TO KEEP THE PERINEUM CLEAN AND IODINE WAS USED TO DISINFECT THE AFFECTED AREA. THE WOUND WAS TREATED WITH TDP (TEDING DIANCIBO PU) INFRARED LAMP. THE PATIENT NOTED THAT THE STINGING PAIN AND ITCHING WERE RELIEVED COMPARED WITH BEFORE.

  Patient problems: Foreign Body Reaction; Inflammation; Itching Sensation; Pain

  MAUDE report 20493364 ↗

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