Polysorb SL-822Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521049345), received between Mar 23, 2019 and Jun 12, 2026 — classified as 7 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER DURING A PROCEDURE, AFTER OPENING THE PACKAGE FOR USE, THE SUTURE BROKE WHEN PULLED AND COULD NOT BE USED. A NEW SYNTHETIC ABSORBABLE SURGICAL SUTURE WAS THEN USED FOR THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25481583 ↗
• MalfunctionFeb 21, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A GYNAECOLOGY PROCEDURE, THE PATIENT HAD A VULVAL BIOPSY AND NEEDED A STITCH TO SECURE HEMOSTASIS, AND WHILE REMOVING THE SUTURE FROM THE PACKAGING, THE SUTURE BROKE ON THE NEEDLE CONNECTION. THE ISSUE OCCURRED ON THREE SUTURES. AN ALTERNATE PRODUCT WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24410423 ↗
• MalfunctionFeb 21, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A GYNAECOLOGY PROCEDURE, THE PATIENT HAD A VULVAL BIOPSY AND NEEDED A STITCH TO SECURE HEMOSTASIS, AND WHILE REMOVING THE SUTURE FROM THE PACKAGING, THE SUTURE BROKE ON THE NEEDLE CONNECTION. THE ISSUE OCCURRED ON THREE SUTURES. AN ALTERNATE PRODUCT WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24410422 ↗
• MalfunctionFeb 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A GYNAECOLOGY PROCEDURE, THE PATIENT HAD A VULVAL BIOPSY AND NEEDED A STITCH TO SECURE HEMOSTASIS, AND WHILE REMOVING THE SUTURE FROM THE PACKAGING, THE SUTURE BROKE ON THE NEEDLE CONNECTION. THE ISSUE OCCURRED ON THREE SUTURES. AN ALTERNATE PRODUCT WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369475 ↗
• MalfunctionNov 13, 2025Break; Break

  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 23540001 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS USED TO CLOSE THE ABDOMINAL INCISION DURING A CESAREAN SECTION. THE POSTOPERATIVE ABDOMINAL INCISION SITE DRESSING REMAINED DRY. HOWEVER, ON THE FIFTH DAY, SLIGHT REDNESS WAS OBSERVED, WITHOUT FEVER. GENTLE PRESSURE ON BOTH SIDES OF THE INCISION RESULTED IN A SMALL AMOUNT OF FAT FLUID EXUDATE, WITHOUT ANY ODOR. FAT LIQUEFACTION AND POOR ABSORPTION OF THE SUTURE DUE TO INDIVIDUAL FACTORS WERE CONSIDERED, LEADING TO AN EXTENDED HOSPITAL STAY. ANTI-INFECTION TREATMENT AND WOUND DRESSING CHANGES WERE CONTINUED, WITH INSTRUCTIONS TO REST AND STRENGTHEN NUTRITION TO PROMOTE WOUND HEALING.

  Patient problems: Erythema; Fluid Discharge

  MAUDE report 23511711 ↗
• MalfunctionNov 6, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, BEFORE USING IT ON THE SKIN, AFTER OPENING, THE THREAD OF THE DEVICE BROKE WHEN IT WAS BEING PULLED. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 23487897 ↗
• MalfunctionNov 4, 2025Break; Break

  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 23471846 ↗
• MalfunctionOct 31, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, BEFORE USING IT ON THE SKIN, AFTER OPENING, THE THREAD OF THE DEVICE BROKE WHEN IT WAS BEING PULLED. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 23444366 ↗
• MalfunctionAug 11, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN ON SKIN SUTURING, THE NEEDLE BROKE WHILE USING CONTINUOUS SUTURING TECHNIQUE. THE SUTURE WAS REPLACED TO RESOLVE THE ISSUE. NO DEVICE COMPONENT FELL INTO PATIENT CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22779031 ↗
• InjuryMay 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SUTURE BROKE AT THE CONNECTION OF THE NEEDLE AND THREAD. THE FIRST STITCH OCCURRED AND THE NEEDLE GOT STUCK IN THE BREAST TISSUE AND WAS LATER REMOVED. IT WAS NOTED THE PATIENT HAD AN X-RAY AND ULTRASOUND TO CONFIRM THAT THE NEEDLE HAD BEEN COMPLETELY REMOVED. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 22102179 ↗
• MalfunctionOct 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CHOLECYSTECTOMY PROCEDURE, WHILE SUTURING AND WHEN THE SURGEON WANTED TO DO THE SECOND STITCH, THE NEEDLE DETACHED AND FELL INTO THE PATIENT'S CAVITY. THE NEEDLE WAS RETRIEVED WITH FINGER SEARCHING, AND FOUND THE NEEDLE BREAKAGE IN TISSUE AND FINALLY CUT THE TISSUE AND GOT THE NEEDLE. THE SURGICAL TIME WAS EXTENDED FOR ABOUT 5¿10 MINUTES. IT WAS NOTED THAT AN ADDITIONAL NEW SUTURE USED WITHOUT AN ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20423827 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, SIX DAYS AFTER A CESAREAN SECTION PROCEDURE, THE PATIENT WAS ADMITTED DUE TO FLUID LEAKING IN THE ABDOMINAL INCISION FOR EIGHT HOURS. UPON PHYSICAL EXAMINATION, THERE WAS A 12 CENTIMETERS (CM) LONG TRANSVERSE SURGICAL INCISION TWO CM ABOVE THE PUBIC SYMPHYSIS IN THE LOWER ABDOMEN, WHICH CAUSED POOR INCISION HEALING. ON THE SAME DAY, A SECONDARY SUTURE SURGERY WAS PERFORMED UNDER LOCAL ANESTHESIA TO PROMOTE WOUND HEALING. IT WAS NOTED THAT THE INDEX WAS NORMAL, THE INCISION SECRETION CULTURE WAS NEGATIVE, AND THE PATIENT WAS TREATED WITH POSTOPERATIVE DISINFECTION, PIPERACILLIN SODIUM-TAZOBACTAM SODIUM ANTI-INFECTION, AND INTRAVENOUS VITAMIN C INJECTIONS TO PROMOTE INCISION HEALING. ON THE FOURTH DAY AFTER THE SECOND SURGERY, THE INCISION WAS STILL EXUDING, THE INCISION WAS EVERTED, AND THE SUTURE WAS NOT ABSORBED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER TREATMENT.

  Patient problems: Fluid Discharge

  MAUDE report 20151054 ↗
• InjuryAug 5, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, 15 DAYS POSTOPERATIVELY, AFTER CESAREAN SECTION DUE TO FETAL DISTRESS, THERE WAS A LITTLE FLUID FROM THE ABDOMINAL INCISION, WHICH WAS YELLOW IN COLOR, ACCOMPANIED BY PUS AND NO ODOR. THE INCISION WAS DISINFECTED AND CLEANED. HOWEVER, AFTER THREE DAYS, THE PATIENT WENT TO THE HOSPITAL AGAIN. THERE WAS FLUID FROM THE ABDOMINAL INCISION, WHICH WAS YELLOW IN COLOR, ACCOMPANIED BY MORE PUS THAN BEFORE. THE PATIENT WAS ADMITTED FOR TREATMENT. ALSO, CONSIDERING THAT THE SUTURE WAS NOT ABSORBED CAUSING POOR HEALING OF THE INCISION.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 19907009 ↗
• MalfunctionAug 31, 2023Break; Patient-Device Incompatibility; Break; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, AFTER A LOWER UTERINE SEGMENT CESAREAN SECTION, THERE WERE CONCERNING ISSUES WITH THE ABDOMINAL INCISION. THE INCISION APPEARED RED, SWOLLEN, AND HAD NOT ABSORBED THE ABSORBABLE SUTURES. THE INCISION WAS ALSO POORLY HEALED, WITH THE PRESENCE OF YELLOW LIQUID DRAINAGE. THIS PROMPTED A VISIT TO THE OUTPATIENT CLINIC, WHERE THE INCISION WAS CLEANED WITH POVIDONE IODINE. UPON EXAMINATION, IT WAS FOUND THAT TWO OF THE 3-0 ABSORBABLE SUTURES HAD BROKEN, AND THE INCISION WAS SLIGHTLY EVERTED. DESPITE THIS, BLOOD SUGAR LEVELS AND INFECTION INDICATORS WERE WITHIN THE NORMAL RANGE. TO ADDRESS THE SITUATION, THE YELLOW LIQUID AND NECROTIC TISSUE WERE REMOVED, AND ASEPTIC ADHESIVE WAS APPLIED, FOLLOWED BY INTENSIFIED DISINFECTION AND DRESSING TO SUPPORT WOUND HEALING.

  Patient problems: Abscess; Impaired Healing; Necrosis

  MAUDE report 17666325 ↗
• InjuryJun 28, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING HYSTEROSCOPY, CURETTAGE, BILATERAL SALPINGOPLASTY UNDER LAPAROSCOPY, TUBAL DRAINAGE AND MYOMECTOMY, WHEN UMBILICUS WAS SUTURED, THE NEEDLE BROKE. AFTER X-RAY AND B-ULTRASOUND EXAMINATION, THE NEEDLE WAS FOUND INCARCERATED IN THE ABDOMINAL WALL. THE SURGEON EXPANDED THE UMBILICAL INCISION, CAREFULLY EXPLORED, AND REMOVED THE SUTURE NEEDLE COMPLETELY.

  Patient problems: Unintended Radiation Exposure; Unspecified Tissue Injury

  MAUDE report 14846901 ↗
• InjurySep 23, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING KNOT TYING AT THE END OF AN OPEN HERNIA PROCEDURE, BOTH NEEDLE AND THREAD HAD BROKEN. THE NEEDLE PART FELL INTO THE PATIENT¿S CAVITY. X-RAY WAS PERFORMED, AND THE NEEDLE PART WAS FOUND. THIS RESULTED TO EXTENDED SURGICAL TIME FOR 1 HOUR DUE TO SEARCHING FOR THE NEEDLE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE.

  Patient problems: Foreign Body In Patient; No Code Available; Unintended Radiation Exposure

  MAUDE report 10573834 ↗
• MalfunctionJul 16, 2019Break; Break

  ACCORDING TO THE REPORTER, WHEN THE PRODUCT WAS OPENED AND ATTEMPTED TO BE USED, THE SUTURE BROKE DURING HYDROLYSIS. IT WAS STATED THAT 38 SUTURES HAD THIS ISSUE DURING THE PROCEDURE. ANOTHER DEVICE FROM ANOTHER LOT NUMBER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8793020 ↗
• MalfunctionJul 16, 2019Break; Break

  ACCORDING TO THE REPORTER, WHEN THE PRODUCT WAS OPENED AND ATTEMPTED TO BE USED, THE SUTURE BROKE DURING HYDROLYSIS. IT WAS STATED THAT 38 SUTURES HAD THIS ISSUE DURING THE PROCEDURE. ANOTHER DEVICE FROM ANOTHER LOT NUMBER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8792978 ↗
• InjuryMar 23, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT LAPAROSCOPIC EXPLORATION AND THE INCISION WAS SUTURED. AFTER 15 DAYS, THE PATIENT RETURNED WITH REPORT OF WOUND PAIN. THE DOCTOR FOUND THAT THE INCISION WAS RED AND SWOLLEN AND THE SUTURE WAS NOT ABSORBED. THE SUTURE WAS REMOVED, AND THE ORNIDAZOLE INJECTION COMBINED WITH LEVOFLOXACIN HYDROCHLORIDE INJECTION WAS USED TO PREVENT INFECTION, AND RECOMBINANT BOVINE BASIC FIBROBLAST GROWTH FACTOR GEL TO PROMOTE WOUND HEALING.

  Patient problems: No Code Available; Pain; Swelling

  MAUDE report 8446572 ↗

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