Polysorb UL-214Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521049505), received between Apr 5, 2018 and Jul 18, 2025 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN EXCISION OF LESIONS, THE THREAD AND NEEDLE BROKE. USED A NEW SUTURE TO FINISH WOUND CLOSURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22545866 ↗
• MalfunctionJul 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN EXCISION OF LESIONS, THE THREAD AND NEEDLE BROKE. USED A NEW SUTURE TO FINISH WOUND CLOSURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22538311 ↗
• MalfunctionJul 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING USE, THE THREAD AND NEEDLE BROKE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22520510 ↗
• MalfunctionFeb 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLE WAS NOT ATTACHED, SO IT COULD NOT BE USED CLINICALLY AND WAS STORED AS IT WAS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502733 ↗
• InjuryAug 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A BROW LIFT PROCEDURE, WHILE ON THE EYEBROW MUSCLE, BOTH SUTURES DETACHED FROM THE NEEDLE AND FELL OFF INTO THE PATIENT CAVITY. AN X-RAY WAS DONE FOR THE PURPOSE OF LOCATING THE COMPONENT, OR CONFIRMING THAT ALL PIECES WERE LOCATED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12332929 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT PRESENTED WITH POST-OPERATIVE WOUND INFECTION WITH WOUND DEHISCENCE AND BUTTON ABSCESS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 9569047 ↗
• InjuryNov 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST UMBILICAL HERNIA PROCEDURE, THE PATIENT CAME BACK WITH AN INFECTION AFTER CLOSURE.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 9274864 ↗
• MalfunctionDec 5, 2018Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE THREAD BROKE, THEY REPLACED THE SUTURE TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8133188 ↗
• MalfunctionMay 23, 2018Break; Knotted; Break; Knotted

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD KNOTTED UP IN A FEW CASES AND THEN BROKE. THEY REPLACED A NEW DEVICE TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7537060 ↗
• MalfunctionApr 5, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE NEEDLE DETACHED EASILY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7399801 ↗

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