Polysorb SL-5626Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521048492), received between Dec 2, 2022 and Jan 5, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionJan 5, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION, THE ABSORBABLE SUTURE WAS USED AND THE MIDLINE BROKE TWICE WHEN SUTURING THE SKIN. THE SUTURE WAS REPLACED IMMEDIATELY TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16104665 ↗
• MalfunctionDec 5, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION, WHEN SUTURING THE SKIN, IT WAS FOUND THAT THE NEEDLE TAIL WAS BROKEN BUT THE REMNANT WAS FOUND IN TIME. THE SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15916585 ↗
• MalfunctionDec 2, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PUERPERA, WHILE UNDERGOING CESAREAN SECTION, THE NEEDLE TAIL OF THE SURGICAL SUTURE WAS FOUND TO BE BROKEN WHEN THE SKIN WAS SUTURED. AFTER DISCOVERY, THE REMNANT WAS FOUND IN TIME. THE SUTURE WAS REPLACED IN TIME TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15906543 ↗

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