Polysorb SL-694Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10884521049253), received between Oct 3, 2017 and Jul 3, 2025 — classified as 2 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER USE OF THE SUTURE ON A VETERINARY PROCEDURE, A WOUND INFECTION OCCURRED. THE PRODUCT WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22401082 ↗
• MalfunctionJun 24, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLES WERE FALLING OFF SUTURE AND SUTURE WAS BREAKING WHEN THE USER TYING THE KNOT.

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

  MAUDE report 22324723 ↗
• MalfunctionJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WERE WOUND INFECTIONS AFTER USING THE SUTURE ON A VETERINARY CASE. THE CUSTOMER, INDICATED THAT THEY EXPERIENCED A SIGNIFICANT NUMBER OF WOUND INFECTIONS FOLLOWING THE USE OF DEVICE WITH A SPECIFIC BATCH NUMBER. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 22124648 ↗
• MalfunctionJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WERE WOUND INFECTIONS AFTER USING THE SUTURE ON A VETERINARY CASE. THE CUSTOMER, INDICATED THAT THEY EXPERIENCED A SIGNIFICANT NUMBER OF WOUND INFECTIONS FOLLOWING THE USE OF DEVICE WITH A SPECIFIC BATCH NUMBER. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 22124345 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE VETERINARY OPERATION ON (B)(6) 2025 TO REMOVE A MASS, TWO SUTURES WERE USED FOR SUBCUTANEOUS CLOSURE. POST-OPERATIVE CONTROL REVEALED WOUND DEHISCENCE, INFECTION, AND WOUND HEALING DELAYS, NECESSITATING A REOPERATION ON (B)(6) DUE TO COMPLICATIONS. AFTER SEVERAL CONTROLS AND MEDICATION, THE PATIENT EVENTUALLY HEALED, AND THE WOUND CLOSED.

  Patient problems: Impaired Healing; Unspecified Infection; Wound Dehiscence

  MAUDE report 21661144 ↗
• MalfunctionOct 2, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER POSTOPERATIVELY, AFTER A REGULAR OVARIECTOMY, THE MUSCULAR WALL WAS SUTURED WITH INCRIMINATED SUTURES WITH CROSSED SINGLE STITCHES AND THE SUTURE LINE DID NOT HOLD. THE PATIENT HAD TO BE REOPERATED IN EMERGENCY IN ANOTHER CLINIC TO FIX DEHISCENCE AND BELLY WALL OPENING. AFTER RE-OPERATION, THE PATIENT WAS OKAY, AND THE MUSCULAR WALL WAS CLOSED WITH ANOTHER SUTURE FROM A DIFFERENT MANUFACTURER.

  Patient problems: Wound Dehiscence

  MAUDE report 20353411 ↗
• MalfunctionSep 20, 2024Unraveled Material; Adverse Event Without Identified Device or Use Problem; Unraveled Material; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A VETERINATY OOPHORECTOMY, THERE WAS DEHISCENCE ON THE MUSCLE WALL WOUNDS WHERE THE DEVICE WAS USED. THIS CAUSED DISEMBOWELMENTS WITH EMERGENCY SURGICAL REVISION. THERE WAS NO TRACE OF INFECTION OBSERVED DURING REVISIONS OR ELEMENTS OF THREAD REJECTIONS.

  Patient problems: Wound Dehiscence

  MAUDE report 20273201 ↗
• MalfunctionSep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A VETERINARY OVARIECTOMY, WHERE THE DEVICE WAS USED FOR MUSCULAR OVERSPRAY WITH SAFETY CROSS DOTS, THE PATIENT HAD WOUND DEHISCENCE ON THE MUSCLE WALLS. THIS CAUSED DISEMBOWELMENTS WITH EMERGENCY SURGICAL REVISION ON THE 13TH OF THE SAME MONTH. THE DEVICE WAS REMOVED AND THE SURGEON USED ANOTHER POLYDIOXANONE (PDS) SUTURE. THERE WAS NO TRACE OF INFECTION OBSERVED DURING REVISIONS OR ELEMENTS OF THREAD REJECTIONS.

  Patient problems: Wound Dehiscence

  MAUDE report 20273008 ↗
• MalfunctionSep 20, 2024Unraveled Material; Adverse Event Without Identified Device or Use Problem; Unraveled Material; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A MONTH AFTER A VETERINARY OVARIECTOMY, WHEREIN THE MUSCULAR BELLY WALLS WERE SUTURED WITH SINGLE STITCHES CROSSED, THERE WAS A SOFT MASS UNDER THE WOUND AS BIG AS A GOLF BALL. TWO DAYS AFTER, THERE WAS A NON-PAINFUL, NON-INFLAMMATORY UNRESECTABLE MASS OF FIVE CENTIMETER (CM) IN DIAMETER AT THE SURGICAL WOUND. ECHOGRAPHY SHOWED DISCONTINUATION OF THE MUSCLE PAIN. IT WAS NOTED THAT THE SUTURE LINE DID NOT HOLD, WHICH RESULTED IN WOUND DEHISCENCE. FOUR DAYS LATER, THE PATIENT WAS RE-OPERATED WITH WITHDRAWAL OF THE SUTURE AND RE-SUTURING WITH POLYDIOXANONE SUTURE. THERE WAS NO TRACE OF INFECTION OBSERVED DURING REVISIONS OR ELEMENTS OF THREAD REJECTIONS. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL.

  Patient problems: Wound Dehiscence

  MAUDE report 20272871 ↗
• MalfunctionMar 14, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A VETERINARY SPAYING PROCEDURE, THE THREAD BROKE DURING THE CLOSING PROCESS. ANOTHER THREAD WAS USED, BUT THE SAME THING OCCURRED AGAIN. THE THREAD BROKE IN THE MIDDLE BETWEEN THE KNOT AND THE CLAMP WHEN CLOSING THE SKIN SUTURE OR SUBCUTIS. THE SURGEON CONTINUED WITH THE PIECE WHAT WAS THERE AND KNOTTED IT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538318 ↗
• MalfunctionMar 9, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A VETERINARY SPAYING PROCEDURE, THE THREAD BROKE DURING THE CLOSING PROCESS. ANOTHER THREAD WAS USED, BUT THE SAME THING OCCURRED AGAIN. THE THREAD BROKE IN THE MIDDLE BETWEEN THE KNOT AND THE CLAMP WHEN CLOSING THE SKIN SUTURE OR SUBCUTIS. THE SURGEON CONTINUED WITH THE PIECE WHAT WAS THERE AND KNOTTED IT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518146 ↗
• MalfunctionMar 9, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A VETERINARY SPAYING PROCEDURE, THE THREAD BROKE. ANOTHER THREAD WAS USED, BUT THE SAME THING OCCURRED AGAIN. THE THREAD BROKE IN THE MIDDLE BETWEEN THE KNOT AND THE CLAMP WHEN CLOSING THE SKIN SUTURE OR SUBCUTIS. THE SURGEON CONTINUED WITH THE PIECE WHAT WAS THERE AND KNOTTED IT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16515797 ↗
• MalfunctionMar 9, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A VETERINARY SPAYING PROCEDURE, THE THREAD BROKE. ANOTHER THREAD WAS USED, BUT THE SAME THING OCCURRED AGAIN. THE THREAD BROKE IN THE MIDDLE BETWEEN THE KNOT AND THE CLAMP WHEN CLOSING THE SKIN SUTURE OR SUBCUTIS. THE SURGEON CONTINUED WITH THE PIECE WHAT WAS THERE AND KNOTTED IT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16514122 ↗
• MalfunctionAug 9, 2021Break; Break

  ACCORDING TO THE REPORTER, THE THREAD OF THE SUTURE BROKE AT THE BEGINNING OF VETERINARY PROCEDURE. ANOTHER SUTURE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12294532 ↗
• MalfunctionFeb 8, 2021Break; Unraveled Material; Break; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVELY ON A VETERINARY PROCEDURE, THE DEVICE THREAD BROKE THAT CAUSED THE WOUND TO RE-OPEN AND INFLAME. TO RESOLVE THE ISSUE, THE VETERINARIAN HAD TO RE-OPERATE THE PATIENT AND USED A NEW SUTURE.

  Patient problems: Inflammation; Wound Dehiscence

  MAUDE report 11292269 ↗
• MalfunctionMay 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A VETERINARY OVARIECTOMY PROCEDURE, THE CAT HAD ABSCESS AND INFECTION. THE CAT NEEDED ANTIBIOTIC THERAPY AND SURGICAL RE-SUTURING.

  Patient problems: Abscess; No Code Available; Unspecified Infection

  MAUDE report 10079238 ↗
• MalfunctionMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A VETERINARY OVARIECTOMY PROCEDURE, THE CAT HAD ABSCESS AND INFECTION. THE CAT NEEDED ANTIBIOTIC THERAPY AND SURGICAL RE-SUTURING.

  Patient problems: Abscess; No Code Available; Unspecified Infection

  MAUDE report 10054954 ↗
• MalfunctionMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A VETERINARY OVARECTOMY PROCEDURE, THE CAT HAD ABSCESS AND INFECTION. THE CAT NEEDED ANTIBIOTIC THERAPY AND SURGICAL RE-SUTURING.

  Patient problems: Abscess; No Code Available; Unspecified Infection

  MAUDE report 10054950 ↗
• MalfunctionMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A VETERINARY OVARECTOMY PROCEDURE, THE CAT HAD ABSCESS AND INFECTION. THE CAT NEEDED ANTIBIOTIC THERAPY AND SURGICAL RE-SUTURING.

  Patient problems: Abscess; No Code Available; Unspecified Infection

  MAUDE report 10054944 ↗
• MalfunctionMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A VETERINARY OVARECTOMY PROCEDURE, THE CAT HAD ABSCESS AND INFECTION. THE CAT NEEDED ANTIBIOTIC THERAPY AND SURGICAL RE-SUTURING.

  Patient problems: Abscess; No Code Available; Unspecified Infection

  MAUDE report 10054937 ↗
• MalfunctionMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A VETERINARY OVARECTOMY PROCEDURE, THE CAT HAD ABSCESS AND INFECTION. THE CAT NEEDED ANTIBIOTIC THERAPY AND SURGICAL RE-SUTURING.

  Patient problems: Abscess; No Code Available; Unspecified Infection

  MAUDE report 10054929 ↗
• MalfunctionMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A VETERINARY OVARECTOMY PROCEDURE, THE CAT HAD ABSCESS AND INFECTION. THE CAT NEEDED ANTIBIOTIC THERAPY AND SURGICAL RE-SUTURING.

  Patient problems: Abscess; No Code Available; Unspecified Infection

  MAUDE report 10054921 ↗
• MalfunctionMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A VETERINARY OVARECTOMY PROCEDURE, THE CAT HAD ABSCESS AND INFECTION. THE CAT NEEDED ANTIBIOTIC THERAPY AND SURGICAL RE-SUTURING.

  Patient problems: Abscess; No Code Available; Unspecified Infection

  MAUDE report 10054916 ↗
• InjuryApr 19, 2020Product Quality Problem; Use of Device Problem; Product Quality Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING THE PATIENT'S WOUND, IT WAS FOUND OUT THAT THE NEEDLE WAS POLISHED UNEVENLY AND HAD A BARB, WHICH INCREASED THE PATIENT'S PAIN AND DAMAGED THE TISSUE MUCOSA. SURGEON REPLACED THE SUTURE TO RESOLVE THE ISSUE.

  Patient problems: Tissue Damage

  MAUDE report 9975901 ↗
• MalfunctionSep 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, WHILE THE SURGEON USED AN INTERRUPTED AND SIMPLE CONTINUOUS SUTURING TECHNIQUE FOLLOWING A SPAY PROCEDURE OF PEDICLE LIGATION, SUB CUTANEOUS AND SUBCUTICULAR CLOSURE, THE PATIENT HAD INCURRED INFLAMMATION, DEHISCENCE INFECTION AND CELLULITIS. THEY USED AN ANTI-INFLAMMATORY, ANTIBIOTIC AND HEALED SECOND INTENTION TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Cellulitis; Inflammation; No Code Available; Organ Dehiscence; Unspecified Infection

  MAUDE report 7859781 ↗

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