Polysorb GL-222Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521045132), received between Jul 22, 2019 and Dec 11, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT PREOPERATIVELY, AFTER OPENING THE STERILE PACKAGING, TWO CONSECUTIVE PACKS WERE FOUND TO BE EMPTY, WITH AN ABSENCE OF BOTH SUTURE AND NEEDLE, AND THESE EMPTY PACKAGES WERE DISCARDED BY THE CIRCULATING NURSE. UPON OPENING THE THIRD PACK, THERE WERE TWO NEEDLES AND SUTURES INSIDE INSTEAD OF ONE. ALL THREE PACKS WERE FROM THE SAME PRODUCT AND LOT, AND ALL ISSUES OCCURRED DURING THE SAME CASE. THE PRODUCT IN THE THIRD PACK WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780812 ↗
• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED THAT DURING A HEMORRHOID PROCEDURE INVOLVING THE MUCOUS MEMBRANE, THE TIP OF THE SUTURE NEEDLE BROKE WHILE SUTURING, AND THE BROKEN NEEDLE TIP FELL INTO THE PATIENT'S CAVITY. THE NEEDLE WAS LOCATED WITHOUT THE NEED FOR IMAGING AND WAS RETRIEVED FROM THE PATIENT CAVITY. IT OCCURRED ON THREE SUTURES. 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 22391259 ↗
• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED THAT DURING A HEMORRHOID PROCEDURE INVOLVING THE MUCOUS MEMBRANE, THE TIP OF THE SUTURE NEEDLE BROKE WHILE SUTURING, AND THE BROKEN NEEDLE TIP FELL INTO THE PATIENT'S CAVITY. THE NEEDLE WAS LOCATED WITHOUT THE NEED FOR IMAGING AND WAS RETRIEVED FROM THE PATIENT CAVITY. IT OCCURRED ON THREE SUTURES. 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 22391208 ↗
• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED THAT DURING A HEMORRHOID PROCEDURE INVOLVING THE MUCOUS MEMBRANE, THE TIP OF THE SUTURE NEEDLE BROKE WHILE SUTURING, AND THE BROKEN NEEDLE TIP FELL INTO THE PATIENT'S CAVITY. THE NEEDLE WAS LOCATED WITHOUT THE NEED FOR IMAGING AND WAS RETRIEVED FROM THE PATIENT CAVITY. IT OCCURRED ON THREE SUTURES. 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 22391198 ↗
• MalfunctionFeb 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SKIN CLOSURE PROCEDURE, THE NEEDLE AND THE THREAD OF THE DEVICE WAS NOT ATTACHED. THE STAFF USED ANOTHER SUTURE TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13485263 ↗
• MalfunctionJul 22, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A DEEP INFERIOR EPIGASTRIC ARTERY PERFORATOR FLAP PROCEDURE, ON WOUND CLOSURE, THE THREAD BROKE. THEY REPLACED WITH ANOTHER SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8812765 ↗

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