Polysorb SL-636Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10884521049062), received between Sep 11, 2017 and Jan 6, 2026 — classified as 4 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Break” (10 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.

• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT DURING A CHILDBIRTH PROCEDURE, AT GRADE 2 RUPTURE, WHILE SUTURING, THE NEEDLE BROKE AND A PIECE OF NEEDLE METAL REMAINED ON THE THREAD. A PART OF THE NEEDLE FELL INTO THE PATIENT'S CAVITY. THE SURGEON HAD TO CUT THE SUTURES INDIVIDUALLY AND, SINCE THE NEEDLE WAS HIDDEN SO WELL AND LAY UPSIDE DOWN IN THE TISSUE, IN THE END THE ENTIRE RUPTURE WAS BASICALLY CUT. AN ULTRASOUND WAS USED TO CHECK FOR ANY REMNANTS. THE SURGEON ALSO COMPARED THE NEEDLE WITH ANOTHER NEEDLE TO ENSURE THAT THE ENTIRE NEEDLE CAME OUT. IT WAS ALSO NOTED THAT THERE WAS A BLOOD LOSS OF APPROXIMATELY 100 MILLILITERS. TO COMPLETE THE CASE, THE ENTIRE SUTURING HAD TO BE TAKEN OUT AND REDONE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23982420 ↗
• MalfunctionJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE USE OF THE THREE SUTURES WERE ASSOCIATED WITH THE DEVELOPMENT OF SERUM AND EDEMA IN CATS FOLLOWING SURGERY.

  Patient problems: Swelling/ Edema

  MAUDE report 22561256 ↗
• MalfunctionJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE USE OF THE THREE SUTURES WERE ASSOCIATED WITH THE DEVELOPMENT OF SERUM AND EDEMA IN CATS FOLLOWING SURGERY.

  Patient problems: Swelling/ Edema

  MAUDE report 22561200 ↗
• MalfunctionJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE USE OF THE THREE SUTURES WERE ASSOCIATED WITH THE DEVELOPMENT OF SERUM AND EDEMA IN CATS FOLLOWING SURGERY.

  Patient problems: Swelling/ Edema

  MAUDE report 22561143 ↗
• MalfunctionJul 12, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A COCHLEAR IMPLANT REMOVAL PROCEDURE, THE NEEDLE OF THE DEVICE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 12153881 ↗
• InjuryJun 11, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE FIXATION OF THE FLAP IN THE MOUTH, THE NEEDLE BROKE IN THE PATIENT¿S MOUTH AND COULD NOT BE FOUND. INTRA-OPERATIVE X-RAY WAS DONE TO LOCATE AND REMOVE THE NEEDLE. THE OPERATION WAS PROLONGED BY ONE HOUR AND 10 MINUTES.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 11987916 ↗
• InjuryAug 20, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS BEING USED TO SUTURE THE MUSCLE DURING AN OPEN TOTAL MASTECTOMY, THE NEEDLE DETACHED FROM THE SUTURE AND FELL INTO THE MUSCLE TISSUE. AN X-RAY WAS PERFORMED TO LOCATE THE COMPONENT AND NEEDLE WAS RETRIEVED. THE EVENTRESULTED TO A UNANTICIPATED PERMANENT TISSUE DAMAGE SINCE SCAR WAS LONGER. THE SURGICAL TIME WAS ALSO EXTENDED TO 30 MINUTES OR MORE AND INCISION WAS EXTENDED TO MORE THAN 1 INCH. ANOTHER SUTURE WAS USED.

  Patient problems: No Code Available; Radiation Exposure, Unintended; Tissue Damage; Unintended Radiation Exposure; Unspecified Tissue Injury

  MAUDE report 10430051 ↗
• MalfunctionMay 4, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, FOLLOWING AN OPEN CASTRATION PROCEDURE ON A VETERINARY CASE, INFLAMMATORY SPOTS AND BUMPS WERE NOTED. ANTIBIOTICS WERE USED TO RESOLVE THE ISSUE. THERE WAS NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10022107 ↗
• MalfunctionMay 4, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, FOLLOWING AN OPEN CASTRATION PROCEDURE ON A VETERINARY CASE, INFLAMMATORY SPOTS AND BUMPS WERE NOTED. ANTIBIOTICS WERE USED TO RESOLVE THE ISSUE. THERE WAS NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10022066 ↗
• MalfunctionMay 4, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, FOLLOWING AN OPEN CASTRATION PROCEDURE ON A VETERINARY CASE, INFLAMMATORY SPOTS AND BUMPS WERE NOTED. ANTIBIOTICS WERE USED TO RESOLVE THE ISSUE. THERE WAS NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10021914 ↗
• MalfunctionMay 4, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, FOLLOWING AN OPEN CASTRATION PROCEDURE ON A VETERINARY CASE, INFLAMMATORY SPOTS AND BUMPS WERE NOTED. ANTIBIOTICS WERE USED TO RESOLVE THE ISSUE. THERE WAS NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10021890 ↗
• MalfunctionMay 4, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, FOLLOWING AN OPEN CASTRATION PROCEDURE ON A VETERINARY CASE, INFLAMMATORY SPOTS AND BUMPS WERE NOTED. ANTIBIOTICS WERE USED TO RESOLVE THE ISSUE. THERE WAS NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10021835 ↗
• MalfunctionMay 4, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, FOLLOWING AN OPEN CASTRATION PROCEDURE ON A VETERINARY CASE, INFLAMMATORY SPOTS AND BUMPS WERE NOTED. ANTIBIOTICS WERE USED TO RESOLVE THE ISSUE. THERE WAS NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10020054 ↗
• InjuryMar 28, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVELY ON A MELANOMA REMOVAL PROCEDURE, 14 DAYS AFTER THE PATIENT NEEDS TO UNDERGO ANOTHER OPERATION DUE TO THE REJECTION OF STITCHES WITH RESECTION OF THE MARGINS OF A RIGHT SHOULDER.

  Patient problems: No Code Available

  MAUDE report 8460457 ↗
• MalfunctionJan 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD A WOUND TREATMENT POST-OPERATIVELY. IT WAS STATED THAT THE PATIENT HAD THE REMAINS OF THE THREAD REMOVED.

  Patient problems: No Code Available

  MAUDE report 8229535 ↗
• MalfunctionJan 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD TO UNDERGO ANTI-BODY OR ANTIBIOTICS ADMINISTRATION AND WOUND TREATMENT.

  Patient problems: Antibiotics, Reaction To; No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 8229523 ↗
• MalfunctionJan 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD AN ANTI-BODY OR ANTIBIOTIC ADMINISTRATION AND WOUND TREATMENT.

  Patient problems: Antibiotics, Reaction To; No Code Available

  MAUDE report 8229522 ↗
• MalfunctionJan 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD AN IRRIGATION OF THE WOUND POST-OPERATIVELY HAD AN ANTIBODY OR ANTIBIOTIC ADMINISTRATION.

  Patient problems: Antibiotics, Reaction To; No Code Available

  MAUDE report 8229510 ↗
• MalfunctionJan 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT HAD TO UNDERGO ANOTHER OPERATION AN ANTI-BODY OR ANTIBIOTIC ADMINISTRATION.

  Patient problems: Antibiotics, Reaction To; No Code Available

  MAUDE report 8229505 ↗
• MalfunctionJan 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD AN INFLAMMATORY POST-OPERATIVELY. THIS RESULTED TO AN EXTENDED INCISION DUE TO THE PRODUCT PROBLEM. ANTIBIOTICS FOR PAIN RELIEF AND ANOTHER PROCEDURE WAS NEEDED TO COMPLETE THE CASE.

  Patient problems: Antibiotics, Reaction To; Inadequate Pain Relief; No Code Available

  MAUDE report 8229499 ↗
• MalfunctionJan 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE PATIENT HAD TO UNDERGO ANOTHER OPERATION FOR THE REMOVAL OF THE THREAD UNDER ANESTHESIA. A NEW SET OF SUTURE WAS USED.

  Patient problems: Awareness During Anesthesia; No Code Available

  MAUDE report 8229496 ↗
• MalfunctionJan 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD THE THREAD REMNANTS REMOVED FOLLOWING A SPLENECTOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8224898 ↗
• MalfunctionJan 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD AN ANTI-BODY OR ANTIBIOTIC ADMINISTRATION AND A WOUND TREATMENT POST-OPERATIVELY.

  Patient problems: Antibiotics, Reaction To; No Known Impact Or Consequence To Patient

  MAUDE report 8224892 ↗
• MalfunctionMay 1, 2018Break; Unraveled Material; Break; Unraveled Material

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE SUTURES BROKE DURING A VETERINARY CASE. THE WOUND HAD BROKEN OPEN AND RE-SUTURING HAD TO BE DONE. THE SUTURE WAS NOTED TO BREAK IN ABOUT SAME PLACE, IN CUTIS, ABOUT 5-7CM FROM THE STITCH. THE SUTURE BROKE IN THE CLINIC. THE KNOTS HAS BEEN LEFT AND SUTURE HAS GONE STRAIGHT OFF. THE CAT DIED.

  Patient problems: No Code Available

  MAUDE report 7478288 ↗
• MalfunctionMay 1, 2018Break; Unraveled Material; Break; Unraveled Material

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE SUTURES BROKE. THE WOUND HAD BROKEN UP AND RE-SURGERY HAD TO BE DONE. THE SUTURE WAS NOTED TO BREAK IN ABOUT SAME PLACE, IN CUTIS, ABOUT 5-7CM FROM THE STITCH. THE SUTURE BROKE IN THE CLINIC. THE KNOTS HAS BEEN LEFT AND SUTURE HAS GONE STRAIGHT OFF. THE CAT WAS READMITTED.

  Patient problems: No Code Available

  MAUDE report 7477703 ↗

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