Polysorb CL-992Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521044302), received between May 13, 2020 and Jan 2, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2026Break

  ACCORDING TO THE REPORTER, DURING A DOUBLE-CHECK OF SUTURE NEEDLE INTEGRITY BEFORE AN OBSTETRIC SURGERY, IT WAS FOUND THAT THE TIP OF ONE TRIANGULAR NEEDLE WAS BROKEN AND INCOMPLETE, WITH A NEAT EDGE. THE SUTURE WAS IMMEDIATELY REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943080 ↗
• InjuryJun 19, 2025Mechanical Problem; Unraveled Material; Patient-Device Incompatibility; Mechanical Problem; Unraveled Material; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT CESAREAN SECTION UNDER SPINAL ANESTHESIA ON (B)(6) 2025, AND THE SKIN WAS SUTURED WITH 2-0 ABSORBABLE SURGICAL SUTURE AFTER SURGERY. THE PATIENT FOUND THAT THE SUTURE WAS EXPOSED 13 DAYS AFTER THE OPERATION, AND THE INCISION WAS SPLIT AND A LITTLE YELLOW SECRETION WAS DEPLOYED. THE PATIENT CAME TO THE DRESSING ROOM OF THE DEPARTMENT TO DEAL WITH THE EXPOSED SUTURE. IT WAS FOUND THAT THE SUTURE WAS NOT ABSORBED AND THE INCISION WAS SPLIT ABOUT 2 X 4 CM. THE SUTURE WAS REMOVED ONE BY ONE AND THE DRESSING WAS CHANGED EVERY DAY. THE WOUND GRADUALLY HEALED ON (B)(6).

  Patient problems: Purulent Discharge; Wound Dehiscence

  MAUDE report 22292185 ↗
• InjuryApr 7, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, ON THE NINTH DAY AFTER CAESARIAN SECTION THE PATIENT RETURNED TO THE HOSPITAL, YELLOW DISCHARGE BEGAN TO APPEAR IN THE WOUND, AND INSPECTION WITH FORCEPS REVEALED THAT THE WOUND WAS NOT HEALED. IN ADDITION, THE SUBCUTANEOUS WOUND AND THE WOUND LINE 4 CENTIMETER DEEP AND 9 CENTIMETER LONG DID NOT ABSORB, AND THE TISSUE SUPPURATED. AFTER DEBRIDEMENT, THE WOUND WAS DRAINED AND THE DRESSING WAS CHANGED. AFTER THE SUTURE WAS REMOVED, THE WOUND BEGAN TO GRADUALLY FORM GRANULATION TISSUE AND HEALED SLOWLY.

  Patient problems: Post Operative Wound Infection; Purulent Discharge

  MAUDE report 16701240 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE ABSORBABLE SUTURE WAS USED TO SUTURE SOFT SUBCUTANEOUS TISSUE FOR CESAREAN SECTION. POSTOPERATIVELY, THE PATIENT HAD POOR POSTOPERATIVE HEALING AND INCISION EXUDATION. THE HEALTH CARE PROVIDER REMOVED THE SUTURE AND CHANGED THE DRESSING ON THE INCISION. AFTER TREATMENT, THE INCISION HEALED THOUGH THE TREATMENT TIME WAS PROLONGED AND THE TREATMENT COST INCREASED.

  Patient problems: Impaired Healing; Purulent Discharge

  MAUDE report 15736806 ↗
• MalfunctionNov 30, 2021Component Missing; Component Missing

  ACCORDING TO THE REPORTER DURING SUTURING PROCESS BOTH INTERMITTENT AND CONTINUES SUTURING. THE PRODUCT WAS OPENED WITHOUT NEEDLE UPON OPENING OF THE PACKAGE. TO RESOLVED THE ISSUE IN THE FIRST INTERMITTENT SUTURE THE SURGEON USED NEW SUTURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12897749 ↗
• InjuryMay 13, 2020Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, AFTER THE CAESAREAN SECTION PROCEDURE, THE SUTURES BROKE INSIDE THE BODY, CAUSING THE PATIENT'S WOUND TO OPEN AND BLEED. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES AND A SECONDARY SURGERY WAS DONE TO RESOLVE THE ISSUE THAT LED TO EXTENDED PATIENT HOSPITALIZATION.

  Patient problems: No Code Available

  MAUDE report 10050648 ↗

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