Sofsilk GSJ-33-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10884521085305), received between Sep 12, 2017 and Oct 28, 2025 — classified as 7 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Break” (22 reports).

13 other recalls cover devices cleared under the same FDA submission (K981128); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A PROCEDURE, TWO OF THE FIVE DETACHABLE NEEDLES HAD BROKEN TIPS. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 23401661 ↗
• MalfunctionOct 28, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A PROCEDURE, TWO OF THE FIVE DETACHABLE NEEDLES HAD BROKEN TIPS. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 23401583 ↗
• MalfunctionSep 5, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC RESECTION, WHILE SUTURING THE INTESTINE, THE NEEDLE TIP DROPPED INTO THE BODY AFTER THE SUTURE. THE NEEDLE WAS REMOVED WITH FORCEPS. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22986906 ↗
• MalfunctionAug 20, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN ILEAL CONDUIT INTESTINAL ANASTOMOSIS SUTURE, THE NEEDLE TIP BROKE AND FELL INTO THE SURGICAL FIELD BUT WAS RETRIEVED WITH FORCEPS. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 22849440 ↗
• MalfunctionMar 7, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE NEEDLE WAS DAMAGED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 21554325 ↗
• MalfunctionJan 3, 2025Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING GASTROINTESTINAL SUTURING, D-TUCH WAS REPORTED AS BEING HARD, ONE OF THE SUTURE CITED FOR ITS HARDNESS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067004 ↗
• MalfunctionJan 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE FOUR NEEDLES DETACHED FROM THE THREAD. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21054883 ↗
• MalfunctionJan 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE FOUR NEEDLES DETACHED FROM THE THREAD. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21054807 ↗
• MalfunctionJan 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE FOUR NEEDLES DETACHED FROM THE THREAD. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21054782 ↗
• MalfunctionJan 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE FOUR NEEDLES DETACHED FROM THE THREAD. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21054749 ↗
• MalfunctionDec 27, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN INTESTINAL ANASTOMOSIS, WHILE SUTURING, THE NEEDLE TIP WAS DAMAGED. NO COMPONENT FELL INTO THE PATIENT'S CAVITY. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025860 ↗
• MalfunctionJul 19, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WERE ONLY FOUR PACKS INSTEAD OF FIVE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19785792 ↗
• MalfunctionFeb 12, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INTESTINAL RESECTION, THE NEEDLE BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 18692498 ↗
• MalfunctionDec 19, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY GASTRECTOMY PROCEDURE, IT WAS FOUND THAT THERE WAS ONE EXCESS PIECE OF NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360030 ↗
• MalfunctionDec 8, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, INTRAOPERATIVE, IT WAS NOTED THAT THE NEEDLE COULD NOT DETACHED FROM THE THREAD. A NEW PRODUCT WAS OPENED, AND THE SURGERY WAS CONTINUED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18296636 ↗
• MalfunctionMay 3, 2023Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING OPEN PANCREATICODUODENECTOMY, THE THREAD BROKE EASILY EVEN THOUGH USUAL TENSION WAS APPLIED. THE THREAD FELT AND LOOKED THINNER. A COMPETITOR 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 16861267 ↗
• MalfunctionApr 27, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CORONARY ARTERY BYPASS GRAFT, WHEN DETACHMENT WAS PERFORMED, WHILE THE NEEDLE TIP WAS CLAMPED WITH THE NEEDLE HOLDER, THE NEEDLE TIP HAD BROKE. THE NEEDLE TIP WAS FOUND IN THE NEEDLE HOLDER. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16828546 ↗
• MalfunctionNov 22, 2022Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, BEFORE USING THE DEVICE ON PATIENT, THE NEEDLE SUTURE COULD NOT BE REMOVED FROM THE PACKAGE EVEN WHEN IT WAS PULLED. THE NEEDLE AND SUTURE GOT DETACHED WHEN IT WAS PULLED WITH FORCE, HENCE, WAS NOT USED. ANOTHER PRODUCT WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15847404 ↗
• MalfunctionNov 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PREPARATION OF THE DEVICE, WHEN THE NEEDLE WAS HELD BY THE NEEDLE HOLDER AND TAKEN OUT OF THE PACKET, THE NEEDLE AND SUTURE CAME OFF. THERE WAS SEVERAL SUTURES THAT HAD THE SAME ISSUE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15812863 ↗
• MalfunctionSep 29, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, WHEN THE NURSE WAS PREPARING FOR THE OPERATION, THE PRODUCT IN QUESTION WAS OPENED AND NOTICED THAT ONE S UTURE WAS MISSING. IT WAS NOT USED FOR THE OPERATION AND A NEW PACKET WAS SENT AND HANDLED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15502396 ↗
• MalfunctionSep 17, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE NEEDLE COUNT DID NOT MATCH, AND WHEN IT WAS CHECKED, IT WAS FOUND THAT ONE PACKET OF THE DEVICE CONTAINED SIX INSTEAD OF FIVE.

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

  MAUDE report 15443087 ↗
• MalfunctionJul 12, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER USING THE DEVICE AND WHEN COUNTING THE NEEDLE, IT WAS DETERMINED THAT 6 WERE CONTAINED IN 1 PACKET. NOTHING IN PARTICULAR WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 14992499 ↗
• MalfunctionJun 14, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN ABDOMINAL DIGESTIVE LAPAROTOMY SURGERY, THE NEEDLE BROKE WHEN IT WAS USED IN NORMAL SUTURE. THE BROKEN NEEDLE TIP DISENGAGED INTO THE PATIENT'S CAVITY, WAS VISUALLY CONFIRMED AND WAS RETRIEVED. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14687700 ↗
• InjuryMay 6, 2022Product Quality Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT HEMICOLON SURGERY, WHILE USED AS A SUPPORT SUTURE AT ANASTOMOSIS OF THE INTESTINE, THE D-TACH DID NOT COME OFF. THE BLOOD VESSEL WAS DAMAGED, AND BLEEDING OCCURRED, SO COMPRESSION HEMOSTASIS WITH GAUZE WAS PERFORMED. ANOTHER PRODUCT WITH ANOTHER LOT WAS USED TO COMPLETE THE CASE AND RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 14307398 ↗
• InjuryMay 6, 2022Product Quality Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT HEMICOLON SURGERY, WHILE USED AS A SUPPORT SUTURE AT ANASTOMOSIS OF THE INTESTINE, THE D-TACH DID NOT COME OFF. THE BLOOD VESSEL WAS DAMAGED, AND BLEEDING OCCURRED, SO COMPRESSION HEMOSTASIS WITH GAUZE WAS PERFORMED. ANOTHER PRODUCT WITH ANOTHER LOT WAS USED TO COMPLETE THE CASE AND RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 14307377 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K981128. One submission often covers many models, so check the product and lot details in each record.

• Z-1697-2024 · Jan 25, 2024 · Open, Classified
  Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use in soft tissue approximation an
• Z-0845-2024 · Dec 21, 2023 · Open, Classified
  Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X
• Z-1176-2023 · Dec 2, 2022 · Open, Classified
  Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SOFSILK* 2-0 BLK 75CM GS11 X36 CS490 CS-562 SOFSILK* 2-0 BLK 75C
• Z-2810-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 0 18" BLACK GS-21 DT non-absorbable braided nylon sutures CS10M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use i
• Z-2814-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 4/0 18" BLACK CV-22 DT non-absorbable silk sutures GS46M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the c
• Z-2815-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 2/0 BLACK 5x18" V-20 D-TACH non-absorbable silk sutures GS62M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in
• Z-2816-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 3/0 18" BLACK V-20 DT non-absorbable braided nylon sutures GS63M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use
• Z-2811-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 3/0 18" BLACK CV-25 DT non-absorbable silk sutures GS33M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the c
• Z-2812-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 5/0 BLACK 5 X 18" CV-22 D*TACH non-absorbable silk sutures GS43M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use
• Z-2813-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 4/0 18" BLACK CV-22 DT non-absorbable silk sutures GS44M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the
• Z-2819-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 0 BLACK 6X 18" PRE-CUT WAX/RACE non-absorbable braided nylon sutures S196 Sofsilk is intended for use in general soft tissue approximation and/or ligation, inclu
• Z-2817-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 2/0 30" BLACK V-20 DT non-absorbable braided nylon sutures GS66M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use
• Z-2818-2011 · Jun 3, 2011 · Terminated
  Syneture Sofsilk 3/0 BK 12X18" PRE-CUT WAX-RACE non-absorbable braided nylon sutures S194 Sofsilk is intended for use in general soft tissue approximation and/or ligation, includ