Polysorb UL-203Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10884521049451), received between Sep 12, 2017 and Jan 22, 2026 — classified as 4 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (17 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Break; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING THE PROCEDURE BUT BEFORE BEING USED ON THE PATIENT, WHILE BEING REMOVED FROM THE RETAINER AND PREPARED PRIOR TO PATIENT INCISION, THE SUTURE WAS BROKEN, AND THERE WAS DIFFICULTY IN REMOVING THE SUTURE FROM THE RETAINER/PACKAGING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24152762 ↗
• MalfunctionJan 21, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SUBMUCOSAL BONE RESECTION OF THE INFERIOR TURBINATE (RIGHT INFERIOR TURBINATE) UNDER NASAL ENDOSCOPY, TURBINATE RESHAPING (LEFT INFERIOR TURBINATE) UNDER NASAL ENDOSCOPY, AND SEPTOPLASTY UNDER NASAL ENDOSCOPY, AFTER FOUR STITCHES, THE NEEDLE AND THREAD DETACHED AND COULD NOT BE USED ANY FURTHER. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24136282 ↗
• MalfunctionDec 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT LAPAROSCOPIC CHOLECYSTECTOMY, WHILE ON CLOSURE OF INCISION, THE DOCTOR FOUND THAT THE NEEDLE HAD SEPARATED FROM THE SUTURE. THE SURGERY WAS IMMEDIATELY PAUSED, AND THE CIRCULATING NURSE AND HEAD NURSE WERE NOTIFIED TO SEARCH FOR THE NEEDLE. THE NEEDLE WAS FOUND IN THE PATIENT¿S MUSCLE LAYER, AND IT WAS INTACT. THE NEEDLE WAS JOINTLY CONFIRMED BY BOTH MEDICAL AND NURSING STAFF, AND NO ADVERSE OUTCOME OCCURRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892664 ↗
• InjuryNov 11, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER TWO STITCHES WERE PLACED, THE NEEDLE BROKE. THE BROKEN NEEDLE AND THE REMAINING SEGMENT WERE IMMEDIATELY REMOVED AND CHECKED FOR COMPLETENESS. THE INCISION WAS REPEATEDLY IRRIGATED, AND POSTOPERATIVE X-RAY FLUOROSCOPY WAS PERFORMED TO CONFIRM THAT NO FOREIGN BODIES REMAINED. THE PRODUCT WAS REPLACED TO COMPLETE THE CASE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 23519440 ↗
• MalfunctionNov 10, 2025Break; Material Frayed; Break; Material Frayed

  ACCORDING TO THE REPORTER, DURING A GENERAL GASTROINTESTINAL SURGERY, UNRAVELING OCCURRED NEAR THE CENTER OF THE SUTURE NEEDLE, AND ACCUMULATION OF THE SUTURE MATERIAL WAS OBSERVED AT THE PERIPHERAL END, RESULTING IN SUTURE BREAKAGE. THE PRODUCT COULD NO LONGER BE USED, AND THE SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512232 ↗
• MalfunctionJul 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A PROCEDURE, IN SKIN INCISION SUTURING THE THREAD AND THE NEEDLE TAIL JOINT DISCONNECTED. THE NEEDLE AS A WHOLE FELL INTO THE PATIENT'S TISSUE. THE SURGEON WAS ABLE TO RETRIEVE THE NEEDLE. THIS RESULTED IN SKIN INJURY. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22641735 ↗
• MalfunctionMay 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SKIN INCISION CLOSURE PROCEDURE, THE CONNECTOR BETWEEN THE SUTURE THREAD AND THE NEEDLE TAIL DISCONNECTED MID-SUTURING. IT WAS NOTED THAT THE SKIN WAS DAMAGED AND THE NEEDLE TIP FELL INTO THE PATIENT¿S TISSUE WHICH WAS PROMPTLY REMOVED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22084669 ↗
• MalfunctionMar 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HIGH LIGATION OF THE INGUINAL HERNIA SAC DUE TO LEFT INCARCERATED HERNIA ON A NEONATE, THE NEEDLE AND THREAD WERE DETACHED AND COULD NOT BE USED NORMALLY. IT WAS NOTED THAT THE NURSE IMMEDIATELY CHECKED THE INTEGRITY OF THE NEEDLE AND FOUND THAT THE NEEDLE WAS INTACT. THE SUTURE WAS IMMEDIATELY REPLACED AND HANDED TO THE SURGEON FOR SUTURING.

  Patient problems: Insufficient Information

  MAUDE report 21715639 ↗
• MalfunctionMar 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN SUTURING THE DIGESTIVE TRACT, THE THREAD GOT DETACHED OFF THE NEEDLE. THE ISSUE OCCURRED TWICE IN A ROW. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21713332 ↗
• MalfunctionMar 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN SUTURING THE DIGESTIVE TRACT, THE THREAD GOT DETACHED OFF THE NEEDLE. THE ISSUE O CCURRED TWICE IN A ROW. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21713323 ↗
• MalfunctionMar 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY MYOMECTOMY, WHEN PASSING THE STITCH IN THE SEROSA OF THE UTERUS, THE NEEDLE WAS DISASSEMBLED FROM THE THREAD. THE SURGEON WITH THE NEEDLE HOLDER MANAGED TO REMOVE IT FROM THE TISSUE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708879 ↗
• MalfunctionJan 3, 2025Break; Break

  ACCORDING TO THE REPORTER DURING THE PARTIAL GASTRECTOMY, WHEN ON GASTROINTESTINAL ANASTOMOSIS SUTURING, THE SUTURE NEEDLE BROKE. THE OPERATION WAS IMMEDIATELY STOPPED AND THE BROKEN END OF THE SUTURE NEEDLE WAS FOUND IN TIME. THE BROKEN PART OF THE NEEDLE TIP WAS FOUND AT THE GASTROEPIPLOIC MEMBRANE. TOOK OUT THE BROKEN END OF THE SUTURE NEEDLE AND COMPARED IT WITH THE REMAINING PART OF THE SUTURE NEEDLE, AND THEN CONTINUED THE OPERATION.

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

  MAUDE report 21065208 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON POST OPERATIVE DEBRIDEMENT AND SUTURE FOR THE PATIENT DIAGNOSED WITH A COMMINUTED FRACTURE OF THE MIDDLE AND OUTER THIRD OF THE RIGHT CLAVICLE, WITH THE FRACTURE ENDS OVERLAPPING AND DISLOCATED. FIVE DAYS AFTER THE SURGERY, THE PATIENT'S SUTURED WOUND SHOWED SYMPTOMS OF POOR SKIN HEALING, REDNESS AND SWELLING. AFTER THE SUTURES WERE REMOVED, INTRAVENOUS DRIP OF CEFUROXIME INJECTION 1.5G WAS GIVEN INTRAVENOUSLY AND DAILY DEBRIDEMENT AND DRESSING WERE PERFORMED.

  Patient problems: Erythema; Impaired Healing; Swelling/ Edema

  MAUDE report 20739179 ↗
• MalfunctionNov 20, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A APPENDECTOMY, WHEN THE KNOT WAS TIED TO PULL THE SKIN TOGETHER, THE SUTURE BROKE. THE DOCTOR TIED THE KNOT AGAIN TO PULL THE SKIN TOGETHER, AND THE SUTURE BROKE AGAIN. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20734133 ↗
• MalfunctionSep 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A RIGHT LOBE SUBTOTAL THYROIDECTOMY AND RIGHT RECURRENT LARYNGEAL NERVE EXPLORATION, WHEN THE WOUND WAS SUTURED, THE SYNTHETIC ABSORBABLE SURGICAL SUTURE HAD THE NEEDLE AND SUTURE DETACHMENT AFTER ONE STITCH. THE NEW SUTURE WAS IMMEDIATELY REPLACED. THE OPERATION WAS SUCCESSFUL AND THE PATIENT WAS RETURNED TO THE WARD SAFELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20273523 ↗
• MalfunctionAug 21, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, A DAY FOLLOWING THE PROCEDURE, WHEREIN SUTURE WAS USED TO SUTURE THE INCISION AFTER THE INTERNAL FIXATION EQUIPMENT WAS REMOVED, IT WAS OBSERVED THAT THE INCISION (WOUND) WAS RED AND SWOLLEN, AND THE SKIN WAS ITCHY AT THE TIME OF CHANGING THE DRESSING. THE INCISION WAS THEN DISINFECTED WITH IODINE AND RE-BANDAGED.

  Patient problems: Foreign Body Reaction; Itching Sensation; Swelling/ Edema

  MAUDE report 20017566 ↗
• MalfunctionAug 20, 2024Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SUTURE BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20007931 ↗
• InjuryJul 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROSTATECTOMY PROCEDURE, THE NEEDLE BECAME LOOSE IN THE PATIENT'S STOMACH AND COULD NOT BE FOUND. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19691218 ↗
• InjuryJun 28, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, THREE DAYS FOLLOWING A SUPERFICIAL TUMOR RESECTION WHEREIN SUTURE WAS USED, THE SUTURE ON THE PATIENT'S WOUND WAS NOT COMPLETELY ABSORBED, THE SUTURE LINE WAS RED AND SWOLLEN, AND SOME SUTURES (KNOTS) WERE DISCHARGED FROM THE SUTURING OPENING. THE PATIENT WAS GIVEN ANTI-INFECTION TREATMENT AND THE ORIGINAL SUTURES WERE REMOVED AND SUTURED AGAIN.

  Patient problems: Inflammation; Unspecified Tissue Injury

  MAUDE report 19637292 ↗
• MalfunctionJun 25, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING THE LOCAL SKIN FLAP ON THE FACE, THE SUTURE LINE DID NOT HOLD. AN ADDITIONAL SUTURE WITHOUT ISSUE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19607196 ↗
• MalfunctionNov 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, WHEN THE SURGEON SUTURED THE INCISION, DISCOVERED THAT THE END OF THE NEEDLE HAD DISCONNECTED FROM THE ABSORBABLE SUTURE. THE NEEDLE'S INTEGRITY WAS IMMEDIATELY FOUND THAT THE NEEDLE IS FOUND INTACT, BUT THE SUTURE AT THE TAIL END WAS BROKEN AND COULD NOT BE USED NORMALLY. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18142718 ↗
• MalfunctionJan 4, 2023Break; Break

  ACCORDING TO THE REPORTER, ON AN OPEN DENTAL MAXILLOFACIAL SUTURE DURING THE FINAL STEP OF KNOTTING ONE MINUTE INTO THE PROCEDURE, WHILE EMPLOYING THE CONTINUOUS SUTURING TECHNIQUE THE THREAD OF TWO SUTURES BROKE. THE THREADS WERE EASILY SNAPPING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE PROCEDURE WAS EXTENDED FOR ONE HOUR DUE TO THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095172 ↗
• MalfunctionJan 4, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN DENTAL MAXILLOFACIAL SURGERY, WHILE SUTURING THE SKIN, THE THREAD BROKE. THE THREAD WAS EASILY SNAPPING. ANOTHER SUTURE WAS USED BUT HAD THE SAME ISSUE. ANOTHER TYPE OF SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 16094246 ↗
• MalfunctionDec 8, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON AN OPEN DENTAL MAXILLOFACIAL SUTURE, DURING THE FINAL STEP OF KNOTTING, ONE MINUTE INTO THE PROCEDURE, WHILE EMPLOYING THE CONTINUOUS SUTURING TECHNIQUE, THE THREAD OF TWO SUTURES BROKE. THE THREADS WERE EASILY SNAPPING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE PROCEDURE WAS EXTENDED FOR ONE HOUR DUE TO THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15940583 ↗
• MalfunctionDec 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION PROCEDURE DUE TO PREMATURE DELIVERY, ON THE LOWER UTERINE SEGMENT, AFTER OPENING THE PACKAGE IT WAS FOUND THAT THE NEEDLE AND SUTURE WAS DETACHED FROM THE JUNCTION OF THE NEEDLE TAIL. IT WAS THEN REMOVED AND REPLACED BY A NEW SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15916723 ↗

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