Polysorb GL-122Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 10884521044968), received between Jun 30, 2017 and Jan 9, 2026 — classified as 10 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Break” (32 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 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Break

  ACCORDING TO THE REPORTER, DURING A GYNECOLOGICAL SURGERY, WHILE CLOSING THE WOUND, THE SUTURE NEEDLE UNEXPECTEDLY BROKE. A NEW SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24023200 ↗
• MalfunctionDec 29, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THERE WERE TWO NEEDLES IN ONE PACKET. A NEW PRODUCT WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918503 ↗
• MalfunctionDec 26, 2025Break; Break

  ACCORDING TO THE REPORTER, ON (B)(6) 2025, A LIVE INFANT WAS DELIVERED VIA SPONTANEOUS VAGINAL DELIVERY. A SYNTHETIC ABSORBABLE SURGICAL SUTURE WAS USED TO CLOSE A FIRST-DEGREE PERINEAL LACERATION. ON (B)(6), THE PATIENT COMPLAINED OF PAIN AT THE PERINEAL LACERATION SUTURE SITE AND CAME TO THE HOSPITAL, WHERE BROKEN SUTURES AND WOUND DEHISCENCE WERE OBSERVED AT THE PERINEAL LACERATION SITE, A WOUND REDNESS AND SWELLING. DAILY PERINEAL DEBRIDEMENT AND DRESSING CHANGES WERE PROVIDED FOR SYMPTOMATIC TREATMENT. AFTER THREE DAYS, THE INCISION AT THE PERINEAL LACERATION SITE HEALED WELL, WITH NO REDNESS OR EXUDATE.

  Patient problems: Erythema; Inflammation; Pain; Swelling/ Edema; Wound Dehiscence

  MAUDE report 23901091 ↗
• MalfunctionDec 26, 2025Break; Break

  ACCORDING TO THE REPORTER, A SYNTHETIC ABSORBABLE SURGICAL SUTURE WAS USED, THE PATIENT COMPLAINED OF PAIN AT THE PERINEAL LACERATION SUTURE SITE, WHERE BROKEN SUTURES AND WOUND DEHISCENCE WERE OBSERVED AT THE PERINEAL LACERATION SITE, A WOUND REDNESS AND SWELLING.

  Patient problems: Inflammation; Pain; Swelling/ Edema; Wound Dehiscence

  MAUDE report 23901083 ↗
• InjuryDec 12, 2025Break; Break

  ACCORDING TO THE REPORTER, ON (B)(6) 2025, A LIVE INFANT WAS DELIVERED VIA SPONTANEOUS VAGINAL DELIVERY WHICH WAS ROUTINELY CLOSED WITH SYNTHETIC ABSORBABLE SURGICAL SUTURE. INTRAPARTUM BLEEDING WAS APPROXIMATELY 250 ML. POSTPARTUM, UTEROTONIC THERAPY AND OTHER TREATMENTS WERE GIVEN. ON THE FOURTH DAY AFTER DELIVERY, THE PATIENT COMPLAINED OF SIGNIFICANT PAIN AT THE PERINEAL LACERATION SUTURE SITE. PHYSICAL EXAMINATION REVEALED PARTIAL DEHISCENCE OF THE PERINEAL SUTURE, MILD REDNESS AND SWELLING, A SMALL AMOUNT OF PALE YELLOW EXUDATE ON THE SURFACE AND BROKEN PERINEAL SUTURES. DISINFECTION AND DRESSING CHANGES WERE PERFORMED, AND THE PATIENT WAS INFORMED IN DETAIL ABOUT HER CONDITION. AT THE PATIENT¿S REQUEST, DRAINAGE AND DEBRIDEMENT TREATMENT WERE PROVIDED, WITH DAILY PERINEAL DEBRIDEMENT AND DRESSING CHANGES FOR SYMPTOMATIC MANAGEMENT, AS WELL AS INTRAVENOUS ANTIBIOTICS FOR INFECTION CONTROL. SUBSEQUENTLY, A SECONDARY DEBRIDEMENT AND SUTURE PROCEDURE WAS PERFORMED AT THE PERINEAL LACERATION SITE. POSTOPERATIVELY, INTRAVENOUS ANTIBIOTICS WERE CONTINUED FOR INFECTION CONTROL. THE INCISION AT THE PERINEAL LACERATION SITE HEALED WELL, WITH NO REDNESS, SWELLING, OR EXUDATE.

  Patient problems: Erythema; Inflammation; Pain; Purulent Discharge; Swelling/ Edema; Wound Dehiscence

  MAUDE report 23788459 ↗
• MalfunctionDec 4, 2025Break; Break

  ACCORDING TO THE REPORTER, ON (B)(6) 2025, A PATIENT UNDERWENT EXCISION AND SUTURING FOR A VULVAR LESION. AFTER THE WOUND WAS CONTINUOUSLY SUTURED USING ABSORBABLE SUTURE, SPONTANEOUS SUTURE BREAKAGE OCCURRED, RESULTING IN WOUND DEHISCENCE. THE WOUND WAS THEN RE-SUTURED FOR THE PATIENT.

  Patient problems: Wound Dehiscence

  MAUDE report 23715241 ↗
• MalfunctionAug 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ARTIFICIAL RIGHT FEMORAL HEAD REPLACEMENT, WHEN SUTURING, THE SUTURE BECAME DETACHED FROM THE NEEDLE BODY. THE SUTURE WAS REPLACED WITH THE NEW SUTURE IMMEDIATELY TO COMPLETE THE SUTURING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22854090 ↗
• MalfunctionJun 19, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293186 ↗
• MalfunctionMay 2, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A CESARIAN SECTION DUE TO ECTOPIC PREGNANCY, DURING A REPAIR OF THE UTERUS, THE TAIL OF THE SYNTHETIC ABSORBABLE SUTURE NEEDLE BROKE. THE SURGEON PROMPTLY REMOVED THE BROKEN NEEDLE FROM THE ABDOMINAL CAVITY AND COMPLETED THE OPERATION WITH A NEW SUTURE. THE HAND WASHING NURSE CONFIRMED THAT THE NEEDLE AND SUTURE WERE INTACT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952017 ↗
• MalfunctionJan 23, 2025Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY THE NEEDLE BROKE. AS A RESOLUTION A NEW SUTURE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219567 ↗
• MalfunctionOct 9, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE WAS BROKEN. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20405173 ↗
• MalfunctionSep 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE OF BOTH DEVICE DETACHED WHILE SUTURING. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311445 ↗
• MalfunctionSep 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A GASTRIC BYPASS PROCEDURE, THE NEEDLE OF BOTH DEVICE DETACHED WHILE SUTURING. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20310206 ↗
• MalfunctionAug 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, AFTER OPENING THE PACKAGE, IT WAS DISCOVERED THAT THE NEEDLE AND SUTURE DETACHED. AFTER REPLACING THE FIRST ONE, THE NEEDLE AND SUTURE WERE DETACHED IN THE SAME WAY. AFTER REPLACING WITH THE THIRD ONE, THE SURGERY CONTINUED.

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

  MAUDE report 19951673 ↗
• MalfunctionAug 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, AFTER OPENING THE PACKAGE, IT WAS DISCOVERED THAT THE NEEDLE AND SUTURE DETACHMENT WHILE STILL IN THE RETAINER. AFTER REPLACING THE FIRST ONE, THE NEEDLE AND SUTURE WERE DETACHED IN THE SAME WAY. AFTER REPLACING WITH THE THIRD ONE, THE SURGERY CONTINUED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 19951332 ↗
• InjuryAug 8, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, 282 DAYS AFTER THE INITIAL PROCEDURE, WHILE PERFORMING AN OPEN CYSTOSCOPY, THE SURGEON NOTICED THAT THE SUTURE WAS COMPLETELY CALCIFIED. THIS ISSUE OCCURRED ON THREE DEVICES. IT WAS NOTED THAT THE PATIENT MUST UNDERGO SURGERY AGAIN.

  Patient problems: Calcium Deposits/Calcification; Foreign Body Reaction

  MAUDE report 19943130 ↗
• MalfunctionMar 8, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, UPON OPENING THE PACKAGE, THE SURGICAL STAFF DOUBLE-CHECKED THE NUMBER OF PACKETS; IT ONLY CONTAINED 35 PACKETS INSTEAD OF 36; ONE PACKET SHORT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18869351 ↗
• MalfunctionMar 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY PACEMAKER IMPLANTATION, THERE WAS A SUBCUTANEOUS SUTURE AND AN UNEXPECTED SEPARATION OF THE NEEDLE FROM THE THREAD. IT OCCURRED ON TWO DIFFERENT SUTURES. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18851465 ↗
• MalfunctionMar 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD AND NEEDLE CAME LOOSE AT THE BASE OF THE THREAD. A COMPETITOR DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837799 ↗
• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A MASTECTOMY, WHILE COLLECTING THE BREAST SUBSTANCE, THE NEEDLE SEPARATED FROM THE STRAND. THE NEEDLE THEN PUNCTURED SOME TISSUE WALLS, AND THE STRAND FELL INTO THE PATIENT CAVITY. THE SURGEON FOUND THE STRAND AND A BOVIE PENCIL TO TREAT THE DAMAGE.

  Patient problems: Tissue Breakdown

  MAUDE report 18713505 ↗
• MalfunctionNov 14, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THERE ARE TWO NEEDLES IN THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18133818 ↗
• MalfunctionJul 11, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN PERFORMING A WOUND CLOSURE, FIVE OF THE SUTURES BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302757 ↗
• MalfunctionMay 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC OVARIAN CYST REMOVAL, WHEN PREPARING THE SUTURE, THE NEEDLE AND SUTURE WERE DETACHED AND BROKE. IT COULD NOT BE USED. THE SAME TYPE OF SUTURE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17014880 ↗
• MalfunctionApr 3, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE IMMEDIATELY OCCURRED AFTER TYING THE SUTURE.

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

  MAUDE report 16670668 ↗
• MalfunctionApr 3, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE IMMEDIATELY OCCURRED AFTER TYING THE SUTURE.

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

  MAUDE report 16668420 ↗

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