Polysorb UL-879Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521049642), received between Feb 21, 2019 and Aug 13, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Break

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

  MAUDE report 50233094 ↗
• MalfunctionAug 13, 2026Break

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

  MAUDE report 50233087 ↗
• MalfunctionJul 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059926 ↗
• MalfunctionJul 28, 2025Break; Break

  ACCORDING TO THE REPORTER, WHILE PERFORMING SUBCUTANEOUS SUTURES, THE CENTER OF THE EIGHT SUTURES WAS DAMAGED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637307 ↗
• MalfunctionJul 28, 2025Break; Break

  ACCORDING TO THE REPORTER, WHILE PERFORMING SUBCUTANEOUS SUTURES, THE CENTER OF THE EIGHT SUTURES WAS DAMAGED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636915 ↗
• MalfunctionJul 28, 2025Break; Break

  ACCORDING TO THE REPORTER, WHILE PERFORMING SUBCUTANEOUS SUTURES, THE CENTER OF THE EIGHT SUTURES WAS DAMAGED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636704 ↗
• MalfunctionJul 28, 2025Break; Break

  ACCORDING TO THE REPORTER, WHILE PERFORMING SUBCUTANEOUS SUTURES, THE CENTER OF THE EIGHT SUTURES WAS DAMAGED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636465 ↗
• MalfunctionJul 28, 2025Break; Break

  ACCORDING TO THE REPORTER, WHILE PERFORMING SUBCUTANEOUS SUTURES, THE CENTER OF THE EIGHT SUTURES WAS DAMAGED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636179 ↗
• MalfunctionJul 28, 2025Break; Break

  ACCORDING TO THE REPORTER, WHILE PERFORMING SUBCUTANEOUS SUTURES, THE CENTER OF THE EIGHT SUTURES WAS DAMAGED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22635892 ↗
• MalfunctionJul 28, 2025Break; Break

  ACCORDING TO THE REPORTER, WHILE PERFORMING SUBCUTANEOUS SUTURES, THE CENTER OF THE EIGHT SUTURES WAS DAMAGED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22634900 ↗
• MalfunctionJul 28, 2025Break; Break

  ACCORDING TO THE REPORTER, WHILE PERFORMING SUBCUTANEOUS SUTURES, THE CENTER OF THE EIGHT SUTURES WAS DAMAGED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE, AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22633054 ↗
• MalfunctionMay 12, 2023Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE THREAD WAS BROKEN WHEN IT WAS TAKEN OUT OF THE PACKAGE. THERE WAS NO PROBLEM WITH THE ADDITIONAL NEW SUTURES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16923705 ↗
• MalfunctionFeb 21, 2019Degraded; Product Quality Problem; Degraded; Product Quality Problem

  ACCORDING TO THE REPORTER, PRIOR TO A HEART PROCEDURE, WHEN THE NURSE OPENED THE SUTURE PACKET, THE THREADS HAD BECOME GREY AND THEY DROPPED SCATTEREDLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8358166 ↗

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