Polysorb UL-202Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10884521049444), received between Oct 5, 2017 and Aug 24, 2026 — classified as 4 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Break” (23 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50418432 ↗
• MalfunctionAug 24, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50418418 ↗
• MalfunctionAug 24, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50418406 ↗
• MalfunctionJul 2, 2026Material Frayed; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING BILATERAL TUBAL ANASTOMOSIS, THE ABSORBABLE SURGICAL SUTURE WAS FOUND TO FRAY UNDER NORMAL USE WITHOUT ANY EXCESSIVE PULLING. AFTER REPLACING IT WITH ANOTHER SUTURE, NO FURTHER BREAKAGE OCCURRED. HOWEVER, THE INCIDENT PROLONGED THE OPERATIVE TIME AND INCREASED BLOOD LOSS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25688054 ↗
• MalfunctionJul 1, 2026Material Frayed; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BILATERAL FALLOPIAN TUBE ANASTOMOSIS, ABSORBABLE SURGICAL SUTURES WERE FOUND TO FRAY WITHOUT FORCEFUL TRACTION. AFTER THEY WERE REPLACED WITH SUTURES OF THE SAME MODEL, NO FURTHER BREAKAGE OCCURRED; HOWEVER, THE SURGICAL TIME WAS PROLONGED AND BLOOD LOSS INCREASED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25677570 ↗
• MalfunctionMay 29, 2026Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE SUTURE THREAD DETACHED FROM THE NEEDLE ON FIRST USE. ANOTHER TWO SUTURES WERE USED AND THE SUTURE THREAD BROKE DURING SUTURING ON TWO SUBSEQUENT USES. AN ADDITIONAL SUTURE WAS REQUIRED AS A REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 25337097 ↗
• MalfunctionMay 29, 2026Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE SUTURE THREAD DETACHED FROM THE NEEDLE ON FIRST USE. ANOTHER TWO SUTURES WERE USED AND THE SUTURE THREAD BROKE DURING SUTURING ON TWO SUBSEQUENT USES. AN ADDITIONAL SUTURE WAS REQUIRED AS A REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 25337061 ↗
• MalfunctionMay 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE SUTURE THREAD DETACHED FROM THE NEEDLE ON FIRST USE. ANOTHER TWO SUTURES WERE USED AND THE SUTURE THREAD BROKE DURING SUTURING ON TWO SUBSEQUENT USES. AN ADDITIONAL SUTURE WAS REQUIRED AS A REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 25336993 ↗
• MalfunctionMay 29, 2026Break

  IT WAS REPORTED THAT DURING AN AXILLARY OSMIDROSIS (GLAND) PROCEDURE, THE DEVICE WAS FOUND TO BE BROKEN AND COULD NOT BE USED. TO RESOLVE THE ISSUE, A NEW ABSORBABLE SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 25334612 ↗
• MalfunctionDec 25, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A THYROIDECTOMY, AN ABSORBABLE SUTURE WAS USED FOR SUBCUTANEOUS CLOSURE. WHEN THE SURGEON TIED THE KNOT AND GENTLY PULLED THE SUTURE, IT BROKE IMMEDIATELY. THE SAME TYPE OF SUTURE FROM THE SAME LOT WAS THEN USED INSTEAD, BUT THE ISSUE PERSISTED. FINALLY, ANOTHER TYPE OF SUTURE WAS CHOSEN TO COMPLETE THE CLOSURE.

  Patient problems: Insufficient Information

  MAUDE report 23891863 ↗
• MalfunctionDec 25, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A THYROIDECTOMY, AN ABSORBABLE SUTURE WAS USED FOR SUBCUTANEOUS CLOSURE. WHEN THE SURGEON TIED THE KNOT AND GENTLY PULLED THE SUTURE, IT BROKE IMMEDIATELY. THE SAME TYPE OF SUTURE FROM THE SAME LOT WAS THEN USED INSTEAD, BUT THE ISSUE PERSISTED. FINALLY, ANOTHER TYPE OF SUTURE WAS CHOSEN TO COMPLETE THE CLOSURE.

  Patient problems: Insufficient Information

  MAUDE report 23891857 ↗
• MalfunctionNov 28, 2025Component Missing; Component Missing

  ACCORDING TO THE REPORTER AFTER THE SURGERY, WHEN THE PATIENT WAS SUTURED, UPON OPENING THE PACKAGING IT WAS CONFIRMED THAT THERE WAS NO NEEDLE ON THE PACK. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 23671524 ↗
• MalfunctionNov 13, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN EAR MASS SURGERY, DURING WOUND CLOSURE, THE SUTURE BROKE MULTIPLE TIMES DURING SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543570 ↗
• MalfunctionOct 19, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A PEDIATRIC SURGERY, AFTER CLEANING THE WOUND WHILE SUTURING, THE USER GENTLY PULLED THE SUTURE TO APPROXIMATE THE WOUND EDGES BUT IT BROKE. A NEW SUTURE WAS THEN USED, WHICH RESULTED IN AN INCREASED PAIN FOR THE PATIENT.

  Patient problems: Intraoperative Pain

  MAUDE report 23333628 ↗
• MalfunctionSep 9, 2025Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC GENERAL SURGERY, WHEN OPENING THE PACKAGE IT WAS DISCOLORED AND WHEN PULLED OUT, IT BROKE. IT OCCURRED ON TEN SUTURES. THE SAME PRODUCT IN ANOTHER BOX WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001596 ↗
• MalfunctionSep 9, 2025Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC GENERAL SURGERY, WHEN OPENING THE PACKAGE IT WAS DISCOLORED AND WHEN PULLED OUT, IT BROKE. IT OCCURRED ON TEN SUTURES. THE SAME PRODUCT IN ANOTHER BOX WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001588 ↗
• MalfunctionSep 9, 2025Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC GENERAL SURGERY, WHEN OPENING THE PACKAGE IT WAS DISCOLORED AND WHEN PULLED OUT, IT BROKE. IT OCCURRED ON TEN SUTURES. THE SAME PRODUCT IN ANOTHER BOX WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001575 ↗
• MalfunctionSep 9, 2025Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC GENERAL SURGERY, WHEN OPENING THE PACKAGE IT WAS DISCOLORED AND WHEN PULLED OUT, IT BROKE. IT OCCURRED ON TEN SUTURES. THE SAME PRODUCT IN ANOTHER BOX WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001526 ↗
• MalfunctionSep 9, 2025Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC GENERAL SURGERY, WHEN OPENING THE PACKAGE IT WAS DISCOLORED AND WHEN PULLED OUT, IT BROKE. IT OCCURRED ON TEN SUTURES. THE SAME PRODUCT IN ANOTHER BOX WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001154 ↗
• MalfunctionSep 9, 2025Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC GENERAL SURGERY, WHEN OPENING THE PACKAGE IT WAS DISCOLORED AND WHEN PULLED OUT, IT BROKE. IT OCCURRED ON TEN SUTURES. THE SAME PRODUCT IN ANOTHER BOX WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001119 ↗
• MalfunctionSep 9, 2025Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC GENERAL SURGERY, WHEN OPENING THE PACKAGE IT WAS DISCOLORED AND WHEN PULLED OUT, IT BROKE. IT OCCURRED ON TEN SUTURES. THE SAME PRODUCT IN ANOTHER BOX WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001107 ↗
• MalfunctionSep 9, 2025Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC GENERAL SURGERY, WHEN OPENING THE PACKAGE IT WAS DISCOLORED AND WHEN PULLED OUT, IT BROKE. IT OCCURRED ON TEN SUTURES. THE SAME PRODUCT IN ANOTHER BOX WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001090 ↗
• MalfunctionSep 9, 2025Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC GENERAL SURGERY, WHEN OPENING THE PACKAGE IT WAS DISCOLORED AND WHEN PULLED OUT, IT BROKE. IT OCCURRED ON TEN SUTURES. THE SAME PRODUCT IN ANOTHER BOX WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001072 ↗
• MalfunctionSep 9, 2025Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC GENERAL SURGERY, WHEN OPENING THE PACKAGE IT WAS DISCOLORED AND WHEN PULLED OUT, IT BROKE. IT OCCURRED ON TEN SUTURES. THE SAME PRODUCT IN ANOTHER BOX WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001039 ↗
• MalfunctionMar 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, BEFORE THE START OF THE PROCEDURE, IT WAS FOUND THAT THE CONNECTION BETWEEN THE NEEDLE AND THE SUTURE WAS DISCONNECTED. THE SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16503935 ↗

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