Polysorb GL-192Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521045101), received between Mar 7, 2019 and Dec 4, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN EXCISION OF BASAL CELL CARCINOMA OF THE LEFT ARM, DURING CLOSURE SUTURING, THE FIRST AND SECOND NEEDLE TIPS BROKE OFF IN SUCCESSION AS THE NEEDLE WAS PULLED THROUGH THE SKIN. THE NEEDLE TIPS FELL INTO THE PATIENT CAVITY. C-ARM IMAGING WAS USED TO LOCATE THE BROKEN NEEDLE TIP, AND THE TIPS WERE RETRIEVED. THE PROCEDURE TIME WAS EXTENDED 20-30 MINUTES DUE TO THE NEED TO LOCATE AND RETRIEVE THE NEEDLE TIPS. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 23719550 ↗
• InjuryDec 4, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN EXCISION OF BASAL CELL CARCINOMA OF THE LEFT ARM, DURING CLOSURE SUTURING, THE FIRST AND SECOND NEEDLE TIPS BROKE OFF IN SUCCESSION AS THE NEEDLE WAS PULLED THROUGH THE SKIN. THE NEEDLE TIPS FELL INTO THE PATIENT CAVITY. C-ARM IMAGING WAS USED TO LOCATE THE BROKEN NEEDLE TIP, AND THE TIPS WERE RETRIEVED. THE PROCEDURE TIME WAS EXTENDED 20-30 MINUTES DUE TO THE NEED TO LOCATE AND RETRIEVE THE NEEDLE TIPS. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 23719531 ↗
• MalfunctionMar 30, 2022Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING AN OPEN NEURO PROCEDURE, THE SURGEON SAID THAT THE NEEDLES WERE BENDING AND POPPING OFF PREMATURELY. TO RESOLVE THE ISSUE, MORE SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13952095 ↗
• MalfunctionMar 8, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A POSTERIOR PHARYNGEAL FLAP, THE NEEDLE IS FOUND BROKEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13700495 ↗
• InjuryDec 10, 2019Break; Break

  ACCORDING TO THE REPORTER, FOLLOWING AN OPEN PYLOROMYOTOMY, THE PATIENT WAS BROUGHT BACK FOR A SECOND SURGERY BECAUSE THE SUTURE BROKE. THE EVENT LED TO EXTENDED PATIENT HOSPITALIZATION.

  Patient problems: No Code Available

  MAUDE report 9447924 ↗
• MalfunctionMar 15, 2019Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE THREAD BROKE, THEY REPLACED THE SUTURE TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8424774 ↗
• MalfunctionMar 7, 2019Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POSTOPERATIVE FROM A SCROTAL PROCEDURE, THE MIDLINE SCROTAL INCISION LOOKS GOOD THOUGH THE UPPER 1 -1.5 CM WOUND HAD OPENED UP. IT WAS STATED THAT IT LOOKED LIKE THE SUTURES HAVE ALREADY ABSORBED IN THIS REGION. THERE WAS NO DRAINAGE, ERYTHEMIA OR SIGNIFICANT SWELLING NOTED. A TOPICAL SKIN ADHESIVE WAS APPLIED OVER THIS UPPER PART OF THE INCISION WITH GOOD RESULTS. THE PATIENT TOLERATED THIS WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Wound Dehiscence

  MAUDE report 8398550 ↗

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