Polysorb GLJ-56-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521045583), received between Nov 1, 2017 and Jul 6, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (2 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.

• MalfunctionJul 6, 2026Break

  ACCORDING TO THE REPORTER, DURING AN ORAL SURGERY, WHEN ATTEMPTING TO SUTURE, THE SUTURE SNAPPED REPEATEDLY AND KEPT BREAKING DURING SUTURING. ANOTHER NEW SUTURE WAS USED WITHOUT ANY ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25722241 ↗
• MalfunctionNov 24, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, ON A LAPAROSCOPIC COLECTOMY, SINCE SIX THREADS WERE FOUND IN THE PACKAGE WHICH SHOULD INCLUDE FIVE THREADS, THE PRODUCT WAS NOT USED. ANOTHER DEVICE WAS UTILIZED JUST IN CASE TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869506 ↗
• MalfunctionDec 12, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, WHILE THE DOCTOR HELD THE NEEDLE AND TAKING THE PRODUCT OUT, THE NEEDLE EASILY DETACHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8154736 ↗
• InjuryNov 1, 2017Manufacturing, Packaging or Shipping Problem; Adverse Event Without Identified Device or Use Problem; Manufacturing, Packaging or Shipping Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER THE SURGERY WAS COMPLETED, IT WAS NOTICED THAT THE NUMBER OF NEEDLES WAS SHORT BY ONE. THE TRAY CONTAINING THE DEVICES WAS CHECKED, AND IT WAS POSSIBLE THAT IT CONTAINED ONLY 4 NEEDLES FROM THE START BUT THEY WERE UNSURE. IT WAS REPORTED THAT THE NURSE SEEMED NOT USED TO THE PROCEDURE AND SHE MIGHT HAVE MISCOUNTED. AN X RAY WAS PERFORMED AND NOTHING WAS FOUND IN THE PATIENT'S CAVITY. THE OPERATING TIME EXTENDED BY MORE THAN 30 MIN. THE PATIENT STATUS WAS NOT LISTED.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 6993038 ↗

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