Polysorb GLS323GMDLRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521212466), received between May 8, 2018 and May 8, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unraveled Material” (1 report).

1 other recall cover devices cleared under the same FDA submission (K963253); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2018Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, WHILE OVER SEWING THE STAPLE LINE DURING A LAPAROSCOPY ON THE RIGHT COLON, THE TWO SUTURES WERE OPENED AND REMOVED FROM THE PACKAGING AT THE START OF THE CASE AND WERE FOUND TO HAVE UNRAVELED. THE SUTURE WAS NOT TREATED OR HYDRATED PRIOR TO USE AND THE SURGEON USED A RUNNING SUTURING TECHNIQUE. THEY HAD TO GET A NEW SUTURE TO REDO AND TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7495894 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963253. One submission often covers many models, so check the product and lot details in each record.

• 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