Polysorb GLS-322Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10884521045651), received between Jun 21, 2019 and Mar 2, 2026 — classified as 9 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SUTURING, THE NEEDLE DETACHED FROM THE THREAD. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484910 ↗
• InjuryOct 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, A NEEDLE DETACHMENT OCCURRED WITH THE SUTURE.

  Patient problems: Insufficient Information; Unintended Radiation Exposure

  MAUDE report 23234260 ↗
• MalfunctionMar 27, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING THE SUBCUTANEOUS, THE DOCTOR FELT THAT THE NEEDLE WAS DULL. THE TECH SAW A SMALL PIECE OF THE NEEDLE WAS BROKEN.

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

  MAUDE report 21708992 ↗
• MalfunctionMar 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE BIOPSY/EXCISION LYMPH NODE OPEN DEEP AXILLARY NODE AND AXILLARY LYMPHADENECTOMY SUPERFICIAL PROCEDURE, WHILE CLOSING THE SKIN, THE NEEDLE POPPED OFF WHEN THE SURGEON WAS DONE SUTURING AND PULLED THE STRAND. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. NO ACTION WAS NECESSARY AS THE SURGEON HAD COMPLETED SUTURING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21679330 ↗
• InjuryFeb 18, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A HYSTERECTOMY PROCEDURE, THE TIP OF THE NEEDLE BROKE AND FELL INTO THE PATIENT'S CAVITY. IT WAS NOTED THAT AN X-RAY WAS NOT PERFORMED AND THE NEEDLE WAS NOT RETRIEVED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21393143 ↗
• InjuryJun 25, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A FEMORAL ARTERY BYPASS GRAFT PROCEDURE, A VERY SMALL PART OF THE NEEDLE TIP BROKE OFF AND FELL INTO THE PATIENT'S CAVITY WHILE SUTURING, AND WAS NOT ABLE TO RETRIEVED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19607283 ↗
• MalfunctionMay 20, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ABDOMINAL MYOMECTOMY, THE SURGEON DISCOVERED A SLIVER OF A NEEDLE TIP HAD BROKEN OFF AT SOME POINT DURING THE CLOSURE. THE BROKEN PORTION WAS NOT LOCATED AND WAS NOT CONFIRMED THAT IT FELL INTO THE PATIENT'S CAVITY HOWEVER, THE GREATER PORTION OF THE BROKEN NEEDLE WAS RETAINED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19356368 ↗
• InjuryMar 7, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN AN OPEN BILATERAL VARICOSE VEIN LIGATION AND STRIPPING, WHILE SUTURING TO CLOSE THE RIGHT GROIN, THE NEEDLE BROKE. THE TIP IF THE NEEDLE FELL INTO THE PATIENT¿S CAVITY. AN X-RAY WAS PERFORMED FOR THE EXPRESS PURPOSE OF LOCATING THE NEEDLE, OR CONFIRMING THAT ALL PIECES WERE LOCATED. THE TIP OF THE NEEDLE WAS LOCATED AND REMOVED. ANOTHER DEVICE FROM THE SAME LOT WAS USED TO CLOSE THE PATIENT AND COMPLETE THE CASE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 16496204 ↗
• MalfunctionDec 8, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ROBOTIC-ASSISTED LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGO OOPHORECTOMY, PRIMARY UMBILICAL HERNIA REPAIR WITHOUT MESH AND LYSIS OF ADHESIONS, AT SUTURE REPAIR OF VAGINAL TISSUE FOLLOWING REMOVAL OF UTERUS, THE NEEDLE TIP AND REMAINING PORTION OF THE NEEDLE FELL INTO THE CAVITY BUT WAS ABLE TO BE RETRIEVED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15947227 ↗
• MalfunctionJun 6, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE CLOSING, THE TIP OF THE NEEDLE BROKE OFF. THE NEEDLE TIP WAS PICK OUT FROM THE INCISION WOUND.

  Patient problems: Insufficient Information

  MAUDE report 14604671 ↗
• MalfunctionMay 20, 2022Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, WHILE TAKING IT OUT OF THE PACKAGING, THE NEEDLE WAS BREAKING OFF. THERE WERE MORE THAN ONE DEFECTIVE DEVICE INVOLVED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

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

  MAUDE report 14459850 ↗
• MalfunctionApr 5, 2022Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING A VENTRAL HERNIA REPAIR PROCEDURE, WHILE REPAIRING THE BOWEL, THE SUTURE UNRAVELED BEFORE THE CASE FINISHED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 14015066 ↗
• MalfunctionMar 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, AS SUTURE WAS BEING PULLED THROUGH THE TISSUE, THE NEEDLE POPPED OF UNEXPECTEDLY.

  Patient problems: Insufficient Information

  MAUDE report 13839541 ↗
• MalfunctionDec 8, 2021Break; Unraveled Material; Break; Unraveled Material

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING SEROSAL BOLSTER SUTURES, THE THREAD BROKE. THE SUTURE UNRAVELED DURING THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 12959573 ↗
• MalfunctionOct 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CLOSING ON AN OPEN CAESARIAN SECTION, THE THREE NEEDLES POPPED OFF THE THREAD. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 12657551 ↗
• MalfunctionAug 16, 2021Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A BILATERAL MASTOPEXY, DURING THE CLOSING INCISION, THE THREADS OF 2 SUTURES BROKE. STAPLES WAS USED TO HOLD BREAST SKIN IN PLACE INSTEAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12324393 ↗
• MalfunctionAug 12, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN BILATERAL MASTOPEXY, ON BREAST INCISION CLOSURE POST BILATERAL MASTOPEXY, THREAD BROKE. AFTER TWO SUTURES WERE USED AND BROKEN, STAPLES WERE USED TO HOLD BREAST SKIN IN PLACE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316310 ↗
• MalfunctionAug 4, 2021Material Twisted/Bent; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC TUBAL STERILIZATION, WHILE CLOSING THE SKIN, THE NEEDLE BENT. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12274263 ↗
• MalfunctionJul 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE NEEDLE POPPED OFF THE THREAD. THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12136342 ↗
• MalfunctionMar 24, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING INTERSTIM PROCEDURE, UPON CLOSING, THE NEEDLE BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11564290 ↗
• InjuryMar 22, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PILONDIAL CYST REMOVAL, NEEDLE TIP OF TWO DIFFERENT SUTURE BROKE OFF. ONE NEEDLE TIP WAS FOUND, BUT THE OTHER WAS NOT. X-RAY WAS TAKEN TO SEARCH FOR THE FOREIGN BODY AT THE END OF THE CASE WHICH WAS NEGATIVE. INITIAL HOSPITAL STAY WAS PROLONGED DUE TO PRODUCT PROBLEM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 11547857 ↗
• InjuryFeb 24, 2021Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE SUTURE WAS USED TO CLOSE THE SKIN ON AN OPEN PROCEDURE AND THE CASE WAS COMPLETED. HOWEVER, THE PATIENT HAD EXCESSIVE INFLAMMATION AROUND THE SUTURE LINE DURING A FOLLOW UP VISIT. THE PATIENT WAS GIVEN STEROIDS TO CALM THE INFLAMMATION.

  Patient problems: Skin Inflammation/ Irritation; Unspecified Tissue Injury

  MAUDE report 11373263 ↗
• MalfunctionOct 14, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE NEEDLE OF THE REPORTED DEVICES BROKE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10679113 ↗
• MalfunctionJul 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SPINAL CORD STIMULATOR REMOVAL PROCEDURE, TWO NEEDLES POPPED OFF THE THREAD. A THIRD SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10224786 ↗
• InjuryJun 17, 2020Break; Dull, Blunt; Material Twisted/Bent; Break; Dull, Blunt; Material Twisted/Bent

  ACCORDING TO THE REPORTER, THE DEVICE NEEDLE BECAME DULL EASILY, TIPS BENT AND LOSES ITS STRENGTH.

  Patient problems: Injury

  MAUDE report 10161620 ↗

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