Polysorb SL-691Recalls & reported problems

Summary

The FDA's MAUDE database contains 116 adverse event reports that list this exact device (DI 10884521049208), received between Sep 29, 2017 and Sep 30, 2026 — classified as 23 injuries, 93 malfunctions.

The most frequently reported specific device problem is “Break” (54 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 116 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  It was reported that during a right thyroid lobectomy and isthmusectomy plus right level VI lymph node dissection, while on skin closure, the suture suddenly broke and suturing could not continue. To avoid delaying the procedure, the circulating nurse checked the expiration date and provided a new suture. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941722 ↗
• MalfunctionJun 29, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING MASTECTOMY, WHEN A SYNTHETIC ABSORBABLE SURGICAL SUTURE WAS PREPARED, THERE WAS A NEEDLE¿SUTURE SE PARATION AND SUTURE BREAKAGE WERE FOUND, MAKING IT UNUSABLE. A NEW SUTURE WAS IMMEDIATELY REPLACED TO COMPLETE THE SUTURING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25661699 ↗
• MalfunctionJun 24, 2026Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE WHILE BEING USED. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES AS A RESULT OF THIS EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25609371 ↗
• MalfunctionJun 8, 2026Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, THE DOCTOR FOUND THAT THE WOUND OF THE PATIENT HAD NOT HEALED AND THE SUTURE WAS NOT ABSORBED. THE DEVICE WAS RETRIEVED AND RETURNED.

  Patient problems: Impaired Healing

  MAUDE report 25422986 ↗
• MalfunctionApr 17, 2026Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, AT THE TIME OF INTRACUTANEOUS SUTURING, THE NEEDLE FRACTURED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912062 ↗
• MalfunctionApr 7, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION, DURING THE FIRST SKIN STITCH, THE NEEDLE AND SUTURE WERE DETACHED AND WAS IMMEDIATELY DISCONTINUED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME EXTENDED BY LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811039 ↗
• MalfunctionMar 17, 2026Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE SURGICAL SUTURE BROKE EASILY DURING USE. THE PRODUCT WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 24622423 ↗
• MalfunctionFeb 18, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LOWER SEGMENT CESAREAN SECTION, THE DEVICE WAS USED FOR WOUND CLOSURE, BUT THE CONNECTION BETWEEN THE NEEDLE AND THE SUTURE COMPLETELY BROKE. ANOTHER SUTURE FROM THE SAME LOT WAS REPLACED FOR THE SURGEON TO COMPLETE THE WOUND CLOSURE, AND THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24380940 ↗
• MalfunctionJan 18, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SECOND LOWER SEGMENT CESAREAN SECTION, THE NEEDLE AND SUTURE BECAME DETACHED WHILE PERFORMING SUBCUTANEOUS COSMETIC CLOSURE WITH 4-0 SYNTHETIC ABSORBABLE SURGICAL SUTURE. THE NEEDLE REMAINED INTACT. ANOTHER 4-0 SYNTHETIC ABSORBABLE SURGICAL SUTURE WAS USED TO COMPLETE THE COSMETIC CLOSURE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24106561 ↗
• MalfunctionJan 7, 2026Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OBSTETRICS PROCEDURE, WHEN TYING A KNOT WITH STANDARD TENSION, THE SUTURE BROKE. THE SURGEON INSPECTED THE SURGICAL FIELD TO CONFIRM THAT NO SUTURE FRAGMENTS REMAINED IN THE DEEP TISSUE.

  Patient problems: Insufficient Information

  MAUDE report 23990405 ↗
• MalfunctionDec 19, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  DUPLICATE OF (B)(4).

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

  MAUDE report 23850831 ↗
• MalfunctionDec 17, 2025Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHILE SUTURING THE INCISION FOR THE PATIENT, THE NEEDLE TIP BROKE. THE BROKEN END WAS REMOVED AND A NEW NEEDLE WAS IMMEDIATELY USED TO RESOLVE THE ISSUE. THE PROCEDURE WAS PROLONGED BUT NOT FOR MORE THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 23834973 ↗
• MalfunctionNov 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, 11 DAYS POST-OPERATIVE OF A CESAREAN SECTION PERFORMED ON (B)(6) 2025 WHERE A SUTURE WAS USED FOR WOUND CLOSURE, POOR HEALING OF THE INCISION WAS OBSERVED WITH A 0.5 × 0.5 CM PURULENT VESICLE APPEARING IN THE SUBCUTANEOUS TISSUE AT THE INCISION SITE. AN ALLERGIC REACTION TO THE SUBCUTANEOUS COSMETIC SUTURE WAS CONSIDERED. THE PUS AND SUTURE KNOT WERE EXPRESSED, AND INCISION DISINFECTION AND CARE WERE INTENSIFIED. AFTER SYMPTOMATIC TREATMENT, THE WOUND HEALED WELL.

  Patient problems: Hypersensitivity/Allergic reaction; Impaired Healing; Purulent Discharge

  MAUDE report 23654360 ↗
• MalfunctionNov 25, 2025Break; Break

  IT WAS REPORTED THAT DURING CONTINUOUS SKIN SUTURING IN OBSTETRIC SURGERY, THE NEEDLE BROKE. THE BROKEN NEEDLE WAS SUBSEQUENTLY LOCATED AND RETRIEVED WITH THE ASSISTANCE OF ULTRASOUND. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23652803 ↗
• MalfunctionNov 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE AND THREAD DETACHED.

  Patient problems: Insufficient Information

  MAUDE report 23568379 ↗
• MalfunctionNov 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, IN SUTURING THE SOFT TISSUE, THE NEEDLE AND THREAD DETACHED. THE NEEDLE END WAS PROMPTLY RETRIEVED. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23566326 ↗
• 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 23539993 ↗
• 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 23539990 ↗
• MalfunctionNov 5, 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 23477087 ↗
• 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 23471872 ↗
• MalfunctionOct 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN INTERRUPTED SKIN SUTURING PROCEDURE IN DERMATOLOGY, THE THREAD OF THE ABSORBABLE SUTURE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 23422935 ↗
• MalfunctionOct 21, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE COULD NOT BE TIED; IT BROKE EACH TIME A KNOT WAS ATTEMPTED. THE PRODUCT WAS REPLACED WITH ANOTHER ONE.

  Patient problems: Insufficient Information

  MAUDE report 23354473 ↗
• MalfunctionOct 21, 2025Break; Break

  ACCORDING TO THE REPORTER, SUTURE COULD NOT BE TIED, IT BROKE EACH TIME A KNOT WAS ATTEMPTED. THE PRODUCT WAS REPLACED WITH ANOTHER ONE.

  Patient problems: Insufficient Information

  MAUDE report 23354294 ↗
• MalfunctionOct 20, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE OUTER PACKING OF THE DEVICE WAS INTACT, BUT THE INNER SUTURE COULD NOT BE KNOTTED. IT BROKE EVERY TIME A KNOT WAS TIED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THIS RESULTED IN A PROLONGED OPERATION.

  Patient problems: Insufficient Information

  MAUDE report 23337377 ↗
• MalfunctionOct 20, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE OUTER PACKAGING WAS INTACT, BUT THE INNER SUTURE COULD NOT BE KNOTTED; IT BROKE EVERY TIME A KNOT WAS TIED. IT WAS NOTED THAT OPERATION TIME WAS INCREASED. THE PRODUCT WAS REPLACED WITH ANOTHER SUTURE TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 23337324 ↗

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