Polysorb CL-21-MGRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521040328), received between Sep 17, 2021 and Nov 5, 2025 — classified as 3 malfunctions.

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

• MalfunctionNov 5, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN-CHEST VALVULAR HEART SURGERY, WHILE ON FASCIA CLOSURE DURING CHEST CLOSURE, THERE WERE ONLY 4 UNITS IN THE PACKAGE OF 5. THE SCRUB NURSE NOTICED WHILE USING THE DEVICE, AND THERE WAS A SUSPICION THAT THE NEEDLE WAS MISSING, SO THE SURGERY WAS TEMPORARILY STOPPED AND IT WAS SEARCHED. NO DEVICE COMPONENT FELL INTO THE PATIENT'S CAVITY. ANOTHER PACKAGE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23473340 ↗
• MalfunctionJul 1, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, UPON OPENING OF THE PACK, IT WAS FOUND THAT IT ONLY CONTAINS FOUR PACKETS INSTEAD OF FIVE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19648786 ↗
• MalfunctionSep 17, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NURSE FOUND OUT THAT THE QUANTITY WAS SHORT IMMEDIATELY AFTER OPENING THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12487950 ↗

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