Polysorb GL-191Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521045095), received between May 8, 2023 and Jun 17, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A INCISIONAL HERNIA, WHILE APPLYING THE SUTURE, THE NEEDLE TIP BROKE OFF. IMAGING WAS REQUIRED TO LOCATE THE NEEDLE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THE SURGEON REMOVED THE NEEDLE WITH A TWEEZERS.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 22249858 ↗
• MalfunctionMay 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE THREAD BROKE AT THE CONNECTION OF THE NEEDLE AND THREAD WHILE SUTURING SUBCUTANEOUSLY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22000346 ↗
• MalfunctionMay 2, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE ABSORBABLE SUTURE, THE THREAD BROKE WHILE SUTURING SUBCUTANEOUSLY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949097 ↗
• MalfunctionMay 8, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BREAST REDUCTION PROCEDURE, THE NEEDLE OF THE SUTURE BROKE WHILE IT WAS BEING GRASPED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16892048 ↗

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