Polysorb GL-302Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521045217), received between Jun 11, 2025 and Aug 14, 2025 — classified as 3 malfunctions.

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

• MalfunctionAug 14, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT TWO THREADS WERE USED TO CLOSE THE ABDOMINAL WALL OF THE PATIENT OF A VETERINARY CASTRATION PROCEDURE, POST OPERATIVELY, THE SEAMS HAD OPENED UP AGAIN. A FOLLOW UP WAS DONE AGAIN WITH THE PATIENT UNDER GENERAL ANESTHESIA AND ABDOMINAL SUTURES WERE USED.

  Patient problems: Tissue Breakdown

  MAUDE report 22810288 ↗
• MalfunctionJun 25, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT TWO THREADS WERE USED TO CLOSE THE ABDOMINAL WALL OF THE PATIENT OF A VETERINARY CASTRATION PROCEDURE, POST OPERATIVELY, THE SEAMS HAD OPENED UP AGAIN. A FOLLOW UP WAS DONE AGAIN WITH THE PATIENT UNDER GENERAL ANESTHESIA AND ABDOMINAL SUTURES WERE USED.

  Patient problems: Tissue Breakdown

  MAUDE report 22332820 ↗
• MalfunctionJun 11, 2025Unraveled Material; Insufficient Device Problem Information; Unraveled Material; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE SUTURES WERE USED TO CLOSE THE ABDOMINAL WALL DURING CASTRATION PROCEDURE PERFORMED UNDER GENERAL ANESTHESIA. POST-OPERATIVELY, THE SUTURE LINE DID NOT HOLD AND THE SEAMS OPENED UP AGAIN. FOLLOW-UP SURGERY WAS REQUIRED UNDER GENERAL ANESTHESIA, WITH REPEAT ABDOMINAL SUTURES.

  Patient problems: Insufficient Information; Tissue Breakdown

  MAUDE report 22185332 ↗

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