Polysorb GL-885Recalls & reported problems

Summary

The FDA's MAUDE database contains 136 adverse event reports that list this exact device (DI 10884521045514), received between Jun 13, 2018 and Jun 10, 2026 — classified as 13 injuries, 123 malfunctions.

The most frequently reported specific device problem is “Break” (103 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 25 most recent of 136 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING, THE NEEDLE AND THREAD DETACHED. TO RESOLVE THE ISSUE, ANOTHER BRAND OF SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25459182 ↗
• MalfunctionApr 29, 2026Component Missing; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, WHEN THE PACKAGE WAS OPENED IN PREPARATION FOR WOUND DEBRIDEMENT AND SUTURING FOR A PEDIATRIC PATIENT, IT WAS FOUND THAT THE SUTURE THREAD WAS PRESENT, BUT THE NEEDLE WAS MISSING. THE SUTURE WAS PROMPTLY REPLACED, AND NO IMPACT OCCURRED TO THE PATIENT.

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

  MAUDE report 25034876 ↗
• MalfunctionApr 17, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION, WHOLE SUTURING, THE NEEDLE DETACHED FROM THE THREAD. SUTURING WAS IMMEDIATELY STOPPED, AND A NEW SUTURE WAS USED INSTEAD TO CONTINUE CLOSURE. THE EVENT DELAYED THE OPERATION TIME.

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

  MAUDE report 24911803 ↗
• InjuryApr 6, 2026Break

  ACCORDING TO THE REPORTER, DURING THE CYSTOSCOPIC LEFT URETER RETROGRADE IMAGING, URETERAL STENT PLACEMENT, AND PYELOURETEROPLASTY, THE ABSORBABLE SUTURE WAS USED TO ANASTOMOSE THE LOWEST POINT OF THE URETERAL MUCOSA WITH THE LOWEST POINT OF THE RENAL PELVIS MUCOSA, AND INTERMITTENT SUTURES WERE PLACED BETWEEN THE ANTERIOR AND POSTERIOR WALLS OF THE URETER AND RENAL PELVIS. DURING SUTURING, THE SUTURE SUSPENDED THE URETER THROUGH THE ABDOMINAL WALL, AND THE SUTURE NEEDLE BROKE. AN ACTIVE SEARCH FOR THE BROKEN SUTURE NEEDLE WAS CONDUCTED. THE DOCTOR FIRST INCISED THE PERITONEUM NEAR THE SUSPECTED BREAK POINT AND CAREFULLY SEARCHED, BUT DID NOT FIND THE NEEDLE. THE RADIOLOGY DEPARTMENT WAS CONTACTED AND A MOBILE X-RAY WAS PERFORMED TO LOCATE THE NEEDLE, WHICH WAS SUCCESSFULLY RETRIEVED. THE SURGERY WAS DELAYED BY ABOUT 30 MINUTES, AND A NEW SUTURE WAS USED TO CONTINUE SUTURING, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Laceration(s); Unintended Radiation Exposure

  MAUDE report 24794563 ↗
• MalfunctionMar 30, 2026Component Missing

  ACCORDING TO THE REPORTER, PRIOR TO USE, IT WAS NOTED THAT THE PACKAGE WAS NEEDLE-FREE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24732205 ↗
• MalfunctionMar 19, 2026Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, UPON INSPECTION, TWO NEEDLE-SUTURE PAIRS WERE FOUND TO BE DETACHED, AND ALL THREE NEEDLES HAD ABSORBABLE SUTURE THAT WAS BRITTLE AND BROKE WITH A SLIGHT PULL. THE PRODUCT WAS NOT USED ON THE PATIENT; IT WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638563 ↗
• MalfunctionMar 19, 2026Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, UPON INSPECTION, TWO NEEDLE-SUTURE PAIRS WERE FOUND TO BE DETACHED, AND ALL THREE NEEDLES HAD ABSORBABLE SUTURE THAT WAS BRITTLE AND BROKE WITH A SLIGHT PULL. THE PRODUCT WAS NOT USED ON THE PATIENT; IT WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638492 ↗
• MalfunctionMar 19, 2026Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, UPON INSPECTION, TWO NEEDLE-SUTURE PAIRS WERE FOUND TO BE DETACHED, AND ALL THREE NEEDLES HAD ABSORBABLE SUTURE THAT WAS BRITTLE AND BROKE WITH A SLIGHT PULL. THE PRODUCT WAS NOT USED ON THE PATIENT; IT WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638442 ↗
• MalfunctionJan 22, 2026Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE SUTURE BROKE. THE PRODUCT HAD TO BE REPLACED WITH A NEW ONE TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24149114 ↗
• MalfunctionJan 22, 2026Break

  ACCORDING TO THE REPORTER, DURING AN OTOLARYNGOLOGICAL SURGERY, DURING SUTURING, THE SUTURE BROKE, AND ITS STRENGTH WAS SIGNIFICANTLY LOWER THAN THE CORRESPONDING SUTURE DIAMETER. THE SUTURE WAS REPLACED, AND IT WAS FOUND THAT THE NEWLY OPENED SUTURE ALSO HAD THE SAME PROBLEM. A NEW BATCH OF SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147216 ↗
• MalfunctionJan 22, 2026Break

  ACCORDING TO THE REPORTER, DURING AN OTOLARYNGOLOGICAL SURGERY, DURING SUTURING, THE SUTURE BROKE, AND ITS STRENGTH WAS SIGNIFICANTLY LOWER THAN THE CORRESPONDING SUTURE DIAMETER. THE SUTURE WAS REPLACED, AND IT WAS FOUND THAT THE NEWLY OPENED SUTURE ALSO HAD THE SAME PROBLEM. A NEW BATCH OF SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147189 ↗
• MalfunctionJan 22, 2026Break

  IT WAS REPORTED THAT UPON JUST OPENING THE PACKAGING, THE THREAD BROKE. THE SUTURE WAS NOT TREATED OR HYDRATED PRIOR TO USE, AND CONTINUOUS SUTURING TECHNIQUE WAS PLANNED. AN ADDITIONAL NEW SUTURE OF THE SAME PRODUCT ID AND LOT NUMBER WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147121 ↗
• MalfunctionDec 30, 2025Break; Break

  ACCORDING TO THE REPORTER, AFTER SURGICAL EXCISION OF A SMALL SKIN LESION ON THE PATIENT'S LEFT FOREARM, THE DERMATOLOGIST USED A SYNTHETIC ABSORBABLE SURGICAL SUTURE FOR INTRADERMAL CLOSURE, BUT THE SUTURE BROKE REPEATEDLY DESPITE MULTIPLE ATTEMPTS. THE SUTURE WAS CHANGED TO A DIFFERENT ABSORBABLE SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23931487 ↗
• MalfunctionDec 25, 2025Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE THREAD OF THE SUTURE BROKE IMMEDIATELY AS IT WAS OPENED. THE ISSUE HAPPENED TO MORE THAN ONE SUTURE. THE SUTURE WAS NOT USED IN THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23891880 ↗
• MalfunctionDec 25, 2025Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE THREAD OF THE SUTURE BROKE IMMEDIATELY AS IT WAS OPENED. THE ISSUE HAPPENED TO MORE THAN ONE SUTURE. THE SUTURE WAS NOT USED IN THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23891867 ↗
• MalfunctionDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A DEBRIDEMENT AND SUTURING PROCEDURE UNDER LOCAL ANESTHESIA, THE NEEDLE AND THREAD DETACHED WHEN USED TO CLOSE A WOUND IN THE ORAL AND MAXILLOFACIAL AREA. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

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

  MAUDE report 23873825 ↗
• MalfunctionDec 2, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A GYNECOLOGY PROCEDURE, WHILE USING THE SUTURE ON THE SKIN AND OVIDUCT, THE THREAD OF THE 42 SUTURES WERE BROKEN. THE WOUND WAS CRACKED DUE TO BREAKAGE DURING SUTURING.

  Patient problems: Tissue Breakdown

  MAUDE report 23691050 ↗
• MalfunctionDec 2, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A GYNECOLOGY PROCEDURE, WHILE USING THE SUTURE ON THE SKIN AND OVIDUCT, THE THREAD OF THE 42 SUTURES WERE BROKEN. THE WOUND WAS CRACKED DUE TO BREAKAGE DURING SUTURING.

  Patient problems: Tissue Breakdown

  MAUDE report 23691016 ↗
• MalfunctionDec 2, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A GYNECOLOGY PROCEDURE, WHILE USING THE SUTURE ON THE SKIN AND OVIDUCT, THE THREAD OF THE 42 SUTURES WERE BROKEN. THE WOUND WAS CRACKED DUE TO BREAKAGE DURING SUTURING.

  Patient problems: Tissue Breakdown

  MAUDE report 23691006 ↗
• MalfunctionDec 2, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A GYNECOLOGY PROCEDURE, WHILE USING THE SUTURE ON THE SKIN AND OVIDUCT, THE THREAD OF THE 42 SUTURES WERE BROKEN. THE WOUND WAS CRACKED DUE TO BREAKAGE DURING SUTURING.

  Patient problems: Tissue Breakdown

  MAUDE report 23690995 ↗
• MalfunctionNov 24, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A GYNECOLOGY PROCEDURE, WHILE USING THE SUTURE ON THE SKIN AND OVIDUCT, THE THREAD OF THE 42 SUTURES WERE BROKEN. THE WOUND WAS CRACKED DUE TO BREAKAGE DURING SUTURING.

  Patient problems: Tissue Breakdown

  MAUDE report 23638427 ↗
• MalfunctionNov 24, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A GYNECOLOGY PROCEDURE, WHILE USING THE SUTURE ON THE SKIN AND OVIDUCT, THE THREAD OF THE 42 SUTURES WERE BROKEN. THE WOUND WAS CRACKED DUE TO BREAKAGE DURING SUTURING.

  Patient problems: Tissue Breakdown

  MAUDE report 23633636 ↗
• MalfunctionNov 24, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A GYNECOLOGY PROCEDURE, WHILE USING THE SUTURE ON THE SKIN AND OVIDUCT, THE THREAD OF THE THREE SUTURES WERE BROKEN. THE WOUND WAS CRACKED DUE TO BREAKAGE DURING SUTURING.

  Patient problems: Tissue Breakdown

  MAUDE report 23633522 ↗
• MalfunctionNov 18, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PENILE LENGTHENING AND CIRCUMCISION UNDER GENERAL ANESTHESIA, WHILE ON INCISION CLOSURE, THE NEEDLE TIP BROKE. THE SURGEON AND THE SCRUB NURSE IMMEDIATELY SEARCHED FOR THE BROKEN PIECE AND LOCATED IT NEAR THE INCISION. THEY COMPARED IT WITH THE REMAINING PART OF THE NEEDLE AND CONFIRMED WITH A DOUBLE CHECK THAT IT WAS COMPLETE. A NEW SUTURE WAS THEN OPENED AND THE OPERATION CONTINUED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 23585500 ↗
• MalfunctionNov 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING THE FALLOPIAN TUBE, DETACHMENT OF THE NEEDLE AND SUTURE OCCURRED. A NEW SUTURE FROM THE SAME LOT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 23566979 ↗

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