Polysorb UL-877Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10884521049628), received between Aug 13, 2017 and Sep 18, 2026 — classified as 1 injury, 49 malfunctions.

The most frequently reported specific device problem is “Break” (29 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Detachment of Device or Device Component

  It was reported that during a laparoscopic hernia procedure, an absorbable suture was applied to fascia using a continuous suturing technique. During the first stitch, the needle and thread detached. No device component fell into the patient cavity. The suture was replaced to resolve the issue. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817491 ↗
• MalfunctionJun 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, PRE-OPERATIVELY, WHEN THE PACKAGE WAS OPENED, THE NEEDLE-SUTURE DETACHMENT WAS OBSERVED AND USE WAS STOPPED BEFORE SUTURING BEGAN. ANOTHER NEW SUTURE OF THE SAME PRODUCT IDENTIFICATION AND LOT WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25659009 ↗
• MalfunctionJun 24, 2026Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, AFTER OPENING THE PACKAGE, THE ABSORBABLE SURGICAL SUTURE WAS FOUND TO BE BROKEN. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25610528 ↗
• MalfunctionFeb 15, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC PROCEDURE, WHEN CLOSING THE TROCAR INCISION, THE NEEDLE AND THREAD BROKE IN A SINGLE PULL. THREE SUTURES HAD THE ISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24341415 ↗
• MalfunctionFeb 15, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC PROCEDURE, WHEN CLOSING THE TROCAR INCISION, THE NEEDLE AND THREAD BROKE IN A SINGLE PULL. THREE SUTURES HAD THE ISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24341410 ↗
• MalfunctionFeb 15, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC PROCEDURE, WHEN CLOSING THE TROCAR INCISION, THE NEEDLE AND THREAD BROKE IN A SINGLE PULL. THREE SUTURES HAD THE ISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24341409 ↗
• MalfunctionFeb 3, 2026Break

  ACCORDING TO THE REPORTER, DURING A BILATERAL INGUINAL AND UMBILICAL HERNIA REPAIR, WHILE USING THE SUTURE, THE TIP OF THE SUTURE BROKE OFF.

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

  MAUDE report 24254786 ↗
• MalfunctionJan 29, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING, THE TIP OF THE SUTURE BROKE OFF. BOTH PIECES OF THE SUTURE WERE VISUALIZED ON THE PATIENT'S SKIN AND REMOVED BY THE SURGEON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24216674 ↗
• MalfunctionJan 16, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE CESAREAN SECTION, WHILE USING SYNTHETIC ABSORBABLE SURGICAL SUTURE FOR SURGICAL CLOSURE, THE DOCTOR ENCOUNTERED NEEDLE AND SUTURE BREAKAGE FOR THE TWO OUT OF FOUR SUTURES. A NEW SUTURE WAS USED TO CONTINUE THE OPERATION, WHICH WAS COMPLETED SUCCESSFULLY. THE SURGICAL TIME WAS PROLONGED BUT NOT MORE THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24099441 ↗
• MalfunctionJan 16, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE CESAREAN SECTION, WHILE USING SYNTHETIC ABSORBABLE SURGICAL SUTURE FOR SURGICAL CLOSURE, THE DOCTOR ENCOUNTERED NEEDLE AND SUTURE BREAKAGE FOR THE TWO OUT OF FOUR SUTURES. A NEW SUTURE WAS USED TO CONTINUE THE OPERATION, WHICH WAS COMPLETED SUCCESSFULLY. THE SURGICAL TIME WAS PROLONGED BUT NOT MORE THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24099059 ↗
• MalfunctionJan 16, 2026Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094974 ↗
• MalfunctionDec 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING, THE SUTURE ALSO BROKE OFF AND FELL INTO THE PATIENT CAVITY. THE SURGEON VISUALIZED THE TIP OF THE SUTURE ON THE PATIENT'S SKIN AND REMOVED BOTH PIECES OF SUTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782709 ↗
• MalfunctionOct 29, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A POST-BURN BODY SURFACE REPAIR SURGERY, THE SUTURE OF THE FISHHOOK HAD POOR TENSILE STRENGTH AND BROKE EASILY. THE SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415712 ↗
• MalfunctionOct 20, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A POST-BURN BODY SURFACE REPAIR SURGERY, THE SUTURE OF THE FISHHOOK NEEDLE HAD POOR TENSILE STRENGTH AND BROKE EASILY. THE SURGERY TIME WAS PROLONGED.

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

  MAUDE report 23337079 ↗
• MalfunctionOct 20, 2025Break; Break

  ACCORDING TO THE REPORTER, THE SUTURE OF THE FISHHOOK NEEDLE HAD POOR TENSILE STRENGTH DURING USE AND BROKE EASILY.

  Patient problems: Insufficient Information

  MAUDE report 23335770 ↗
• MalfunctionJul 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC-ASSISTED MYOMECTOMY, DURING CLOSING THE TROCAR HOLE BY SUTURING TEN MINUTES AFTER THE REMOVAL OF THE SUTURE FROM THE PACKAGING. THE NEEDLE AND THREAD WERE BROKEN. THE SUTURE WAS REMOVED AND A NEW ONE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505472 ↗
• MalfunctionJul 9, 2025Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ASSISTED MYOMECTOMY, WHEN THE NEEDLE AND THREAD OF THE SUTURE WERE FOUND TO BE SEPARATED. A NEW SUTURE WAS REPLACED AND EVERYTHING WAS NORMAL. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 22465049 ↗
• MalfunctionNov 5, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN FINALLY SUTURED AND CLOSED THE SHEATH CLIP HOLE, THE SUTURE WAS OPENED, AND IT WAS FOUND THAT THERE WERE TWO SUTURES IN ONE PACKAGE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609786 ↗
• MalfunctionOct 1, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN SUTURING, THE THREAD BROKE WHEN IT WAS PULLED. A NEW PACKAGE OF SUTURE WAS OPENED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 20346456 ↗
• MalfunctionSep 12, 2024Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING THE MYOMECTOMY, WHEN OPENED FOR INSPECTION, THE SUTURE BROKE AS SOON AS IT WAS PULLED, AND THE THREAD TURNED WHITE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20197489 ↗
• MalfunctionJul 22, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE DOCTOR WAS SUTURING TO CLOSE THE TISSUE, THE SUTURE BROKE AS SOON AS IT WAS PULLED, THE SAME SUTURE BROKE ONCE WHEN TYING A KNOT, AND BROKE AGAIN WHEN TYING THE KNOT AGAIN. IT BROKE TWICE IN TOTAL. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19794110 ↗
• MalfunctionJul 17, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN THE SURGEON WAS SUTURING THE PATIENT'S INCISION, THE SUTURE WAS BROKEN AFTER A LITTLE FORCE. IT WAS PULLED AGAIN WITH A LITTLE MORE FORCE, AND IT STILL BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19761513 ↗
• MalfunctionApr 29, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING EMERGENCY LAPAROSCOPIC CHOLECYSTECTOMY, WHEN FIXED THE SUB-HEPATIC DRAINAGE TUBE AND CLOSED THE ABDOMINAL WHITE LINE OF THE UMBILICAL INCISION, USED BRAIDED ABSORBABLE SURGICAL SUTURE TO TIE KNOT, THE SUTURE WAS BROKEN UNDER LOW TENSION. IMMEDIATELY REPLACED IT WITH A NEW ONE AND SUTURED FOR THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19199387 ↗
• MalfunctionFeb 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AS SOON AS THE PACKAGE WAS OPENED, IT WAS SEEN THAT THE NEEDLE AND THREAD WERE SEPARATED FOR BOTH DEVICE. ANOTHER DEVICE FROM ANOTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18692477 ↗
• InjuryJan 9, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE SURGEON WAS SUTURING THE UMBILICAL SKIN LAYER, THE TIP OF THE SUTURE NEEDLE BROKE AT ABOUT 0.5-1MM. THE SURGEON IMMEDIATELY STOPPED, SEARCHED REPEATEDLY NEAR THE SUTURE AREA, AND PERFORMED C-ARM FLUOROSCOPY AT THE SAME TIME. IT WAS CONFIRMED THAT IT WAS NOT IN THE PATIENT'S BODY OR IN THE SKIN OF THE PATIENT'S UMBILICAL INCISION, AND THEN THE PATIENT WAS GIVEN ROUTINE SKIN LAYER SUTURE AND DRESSING COVERAGE. IN ORDER TO AVOID RESIDUE, THE SURGERY TIME WAS PROLONGED AND THE RADIATION HAZARD WAS INCREASED.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 18477698 ↗

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