Polysorb UL-102Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10884521049413), received between Jan 5, 2018 and Aug 13, 2026 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50233014 ↗
• MalfunctionApr 28, 2026Break

  ACCORDING TO THE REPORTER, AFTER COMPLETION OF A FLAP RECONSTRUCTION FOR MUCOSAL SQUAMOUS CELL CARCINOMA, SUTURING OF THE WOUND WAS PERFORMED. DURING CLOSURE, FRACTURE OF THE SUTURE NEEDLE OCCURRED WHILE SUTURING THE WOUND, AND THE SUTURE WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019816 ↗
• MalfunctionFeb 6, 2026Break

  IT WAS REPORTED THAT DURING AN OPEN ORAL COSMETIC SUTURING PROCEDURE, WHILE SUTURING THE ORAL TISSUE, NEEDLE BREAKAGE OCCURRED BUT DID NOT FALL INTO THE PATIENT CAVITY. THE ISSUE WAS RESOLVED BY REPLACING THE SUTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278989 ↗
• InjuryDec 20, 2025Break; Unraveled Material; Break; Unraveled Material

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT EYELID SUTURING ON (B)(6) 2025, DUE TO AN EYELID LACERATION AND RECEIVED SURGICAL SUTURE TREATMENT. ON (B)(6), IT WAS FOUND THAT THE WOUND AT THE SUTURE SITE HAD DEHISCED AND THE SUTURE HAD BROKEN WITH KNOTS STILL PRESENT, SO THE PATIENT RETURNED TO THE HOSPITAL FOR TREATMENT. AFTER ADMISSION, THE DOCTOR CLEANED THE UNHEALED WOUND AND RE-SUTURED THE DEHISCED AREA. IT WAS CONFIRMED THAT THE RE-SUTURING WAS DUE TO THE USER OPERATION AND NOT RELATED TO PRODUCT QUALITY. THE PATIENT IS RECOVERING WELL.

  Patient problems: Wound Dehiscence

  MAUDE report 23858451 ↗
• MalfunctionNov 19, 2025Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER DURING AN OPEN PLASTIC SURGERY INCISION CLOSURE, WHILE PERFORMING A CONTINUOUS SUTURING TECHNIQUE, THE SUTURE DID NOT FLOW SMOOTHLY. THE SURGEON RE-STITCHED THE TISSUE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23590988 ↗
• MalfunctionJun 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT SURGERY TO REMOVE THE PREAURICULAR CYST AND NASOLABIAL FOLD PIGMENTED NEVUS. THE DEVICE WAS USED TO REDUCE TENSION AND PREVENT SCARS. AFTER THE SUTURE WAS REMOVED, THE SKIN WOUND SURFACE RECOVERED WELL AND WAS SMOOTH WITHOUT REDNESS, SWELLING OR ULCERATION. HOWEVER, TWO WEEKS AFTER THE SUTURE WAS REMOVED, THE INTRADERMAL SUTURE WAS REJECTED, WITH LOCAL REDNESS AND SWELLING, WHITE PUS, EXUDATION, PAIN, AND THE WOUND DID NOT HEAL FOR A LONG TIME. THE PATIENT'S WOUND WAS CLEANED PROMPTLY. THE PATIENT CAME BACK FOR A FOLLOW-UP VISIT TO REMOVE THE INTRADERMAL SUTURE, AND THE WOUND GRADUALLY HEALED, BUT IT WAS STILL SLIGHTLY RED AND SWOLLEN.

  Patient problems: Erythema; Impaired Healing; Pain; Purulent Discharge; Swelling/ Edema

  MAUDE report 22153650 ↗
• MalfunctionJan 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE GYNECOLOGICAL PLASTIC SURGERY, AFTER UNPACKING, UPON REMOVAL OF THE SUTURES, BOTH THE NEEDLE AND THREAD BROKE FOR THREE CONSECUTIVE TIMES. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207569 ↗
• MalfunctionJan 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE GYNECOLOGICAL PLASTIC SURGERY, AFTER UNPACKING, UPON REMOVAL OF THE SUTURES, BOTH THE NEEDLE AND THREAD BROKE FOR THREE CONSECUTIVE TIMES. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207561 ↗
• MalfunctionJan 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE GYNECOLOGICAL PLASTIC SURGERY, AFTER UNPACKING, UPON REMOVAL OF THE SUTURES, BOTH THE NEEDLE AND THREAD BROKE FOR THREE CONSECUTIVE TIMES. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207512 ↗
• MalfunctionSep 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A FACIAL DEBRIDEMENT PROCEDURE, THE NEEDLE AND THE THREAD WERE DETACHED WHEN SUTURING THE PATIENT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20204280 ↗
• MalfunctionNov 11, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC BLADDER SURGERY, URETHRAL SUTURING, THE NEEDLE BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18116966 ↗
• MalfunctionMar 31, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN INJURY PROCEDURE, WHEN THE SURGEON OPENED THE PACKAGE IT WAS FOUND THAT SUTURES WERE BROKEN. REPLACED WITH A NEW SUTURE TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 16655929 ↗
• MalfunctionJan 27, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING DEBRIDEMENT AND SUTURE UNDER LOCAL ANESTHESIA FOR MAXILLOFACIAL TRAUMA, THE NEEDLE BROKE SUDDENLY WHEN IN USE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16256340 ↗
• MalfunctionJul 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A TREATMENT FOR MAXILLOFACIAL TRAUMA WHERE THE PATIENT UNDERWENT DEBRIDEMENT AND SUTURE, DURING SUTURING, THE NEEDLE AND THREAD DETACHED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15000011 ↗
• MalfunctionMar 19, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT PYELOPLASTY PROCEDURE, WHILE THE SURGEON SUTURED THE PELVIS AND URETER USING, THE NEEDLE BROKE DURING THE THIRD STITCH, AND 2/3 OF THE NEEDLE TIP FELL INTO THE ABDOMINAL CAVITY. THE NEEDLE TAIL AND BROKEN NEEDLE TIP WERE TAKEN OUT COMPLETELY. THE SURGEON CONTINUED THE OPERATION TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13827602 ↗
• MalfunctionFeb 24, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE THE SKIN WAS BEING PUNCTURED TO BE SUTURED, THE NEEDLE BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13592252 ↗
• MalfunctionJul 8, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A MAXILLOFACIAL DEBRIDEMENT AND SUTURE OPERATION, WHEN THE DOCTOR PUNCTURED THE SKIN AND INSERTED THE NEEDLE, THE NEEDLE WAS BROKEN AND IT COULD NOT BE USED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12134837 ↗
• MalfunctionJan 6, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING RIGHT SPERMATIC SHEATH CYSTECTOMY, WHEN THE FIRST SUTURE NEEDLE WAS USED, THE SUTURE NEEDLE WAS BROKEN. THE OPERATION WAS STOPPED IMMEDIATELY AND THE INCISION WAS PROTECTED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Information

  MAUDE report 9552816 ↗
• InjuryDec 8, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE A SUCCESSFUL LAPAROSCOPIC APPENDECTOMY, THE PATIENT CALLED IN DUE TO REDNESS, SWELLING, PAIN AND CALLED INCISION DRAINAGE. IT WAS NOTED THAT THE CABLE HEAD DID NOT ABSORB. AN IMMEDIATE USE OF DISPOSABLE INCISION KIT DISINFECTION TREATMENT, CLEANED UP THE THRUM OF THE ABSORPTION AND GAVE IODINE VOLTS DISINFECTION, ANTI-INFLAMMATORY ORAL AMOXICILLIN DISPERSIBLE TABLETS AND ADVERSE REACTIONS IMPROVED.

  Patient problems: Inflammation; No Code Available; Pain; Swelling

  MAUDE report 9435138 ↗
• MalfunctionJun 21, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A PAROTID TUMOR RESECTION WHEN SUTURING THE MUSCULAR LAYER, THE BOTTOM NEEDLE AND THE SUTURE GOT SEPARATED. THE PRODUCT WAS REPLACED, AND THE OPERATION CONTINUED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7624746 ↗
• MalfunctionJan 5, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A COSMETIC PLASTIC SURGERY, THE THREAD BROKE AND THERE WAS A NEEDLEWORK SEPARATION. THEY USED A NEW DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7169448 ↗

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