Coated VICRYL J570GRecalls & reported problems

Summary

The FDA's MAUDE database contains 170 adverse event reports that list this exact device (DI 10705031041318), received between Oct 1, 2018 and Sep 30, 2026 — classified as 14 injuries, 156 malfunctions.

The most frequently reported specific device problem is “Break” (123 reports).

6 other recalls cover devices cleared under the same FDA submission (K022269, K183183); 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 170 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Separation

  It was reported that a patient underwent a Tumor Resection procedure on (b)(6) 2026 and suture was used. At 9:45, the patient had surgery due to lip tumor. When suturing with suture during surgery, the problem of pulling off suture needle happened, and the same batch of surgical suture was immediately replaced to complete the subsequent surgery. Extended the surgery time. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944788 ↗
• MalfunctionSep 23, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868782 ↗
• MalfunctionSep 23, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6)2026 and suture was used. It was reported that the suture was broken when the surgeon attempted to sew the tissue. Total 3 products occurred suture breakage issue. Changed another one to complete the surgery. There is no patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868781 ↗
• MalfunctionSep 23, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868780 ↗
• MalfunctionSep 21, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. The customer experienced thread breakage while using the sewing products. There were no patient consequences reported. There were no surgical delays reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843066 ↗
• MalfunctionSep 21, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843064 ↗
• MalfunctionSep 21, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. The customer experienced thread breakage while using the sewing products. There were no patient consequences reported. There were no surgical delays reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843063 ↗
• MalfunctionSep 21, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6)2026 and suture was used. It was reported that the suture was broken when the surgeon attempted to sew the tissue. Changed another one to complete the surgery. There were no patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843041 ↗
• MalfunctionAug 27, 2026Material Frayed

  It was reported that a patient underwent an unknown procedure on (b)(6)2026 and suture was used. Suture drawn & Suture split. This case is from health authority. There were issues such as splitting and drawing during use, affecting the clinical trial, which was replaced in time. There were no patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50478203 ↗
• MalfunctionAug 24, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50412656 ↗
• MalfunctionAug 24, 2026Break; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50412490 ↗
• MalfunctionAug 24, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50411479 ↗
• MalfunctionAug 3, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50117779 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent strabismus surgery on an unknown date and suture was used for muscle-to-sclera fixation. The patient developed a highly symptomatic granuloma. The patient required additional medical treatment with topical cyclosporine 2% for two months, following a one-month course of topical corticosteroid therapy that was reportedly well followed. Additional information was requested.

  Patient problems: Granuloma

  MAUDE report 50098096 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent strabismus surgery on an unknown date and suture was used for muscle-to-sclera fixation. The patient developed a highly symptomatic granuloma. The patient required additional medical treatment with topical cyclosporine 2% for two months, following a one-month course of topical corticosteroid therapy that was reportedly well followed. Additional information was requested.

  Patient problems: Granuloma

  MAUDE report 50098095 ↗
• MalfunctionApr 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INTERMITTENT EXOTROPIA SURGERY UNDER GENERAL ANESTHESIA PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO INTERMITTENT EXOTROPIA AND UNDERWENT SURGERY. THE SURGICAL PROCESS WAS SMOOTH, AND THE WOUND WAS SUTURED AT THE END OF THE SURGERY. AFTER UNPACKING THE SUTURE PACKAGING, IT WAS FOUND THAT THE SUTURE WAS BROKEN AND COULD NOT BE USED. THE DOCTOR REPLACED THE PACKAGING WITH A NEW SUTURE TO SUTURE THE WOUND AND ENDED THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25045301 ↗
• MalfunctionApr 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN STRABISMUS PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE PATIENT EXPERIENCED ALTERNATING INWARD DEVIATION OF VISUAL OBJECTS IN BOTH EYES FOR UNKNOWN REASONS 10 YEARS AGO, ACCOMPANIED BY DOUBLE SHADOWS IN THE HORIZONTAL DIRECTION, WITHOUT SIGNIFICANT VISUAL IMPAIRMENT. WEARING FRAME GLASSES FOR A LONG TIME FOR 7 YEARS WITHOUT SEEKING MEDICAL ATTENTION, THE CONDITION GRADUALLY WORSENED DURING THIS PERIOD. THE PATIENT CAME TO THE HOSPITAL FOR TREATMENT AND WAS ADMITTED WITH ACUTE CONCOMITANT STRABISMUS FOR SURGICAL INTERVENTION. AT THE END OF THE SURGERY, WHEN THE WOUND WAS SUTURED, THE PACKAGE WAS UNPACKED AND IT WAS FOUND THAT THE SUTURE ON THE NEEDLE WAS NOT SECURE. THE DOCTOR REPLACED THE PACKAGE WITH A NEW SET OF SUTURES TO SUTURE THE PATIENT'S WOUND, ENDING THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044970 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT ENTROPION SURGERY OF THE LOWER EYELID IN THE LEFT EYE ON (B)(6) 2025 AND SUTURE WAS USED. THE EYELID MARGIN SKIN WAS CUT OPEN, PEELED, AND SUTURED. THE PATIENT WAS RECHECKED THE NEXT DAY AND NO REDNESS, SWELLING, SUPPURATION, OR INFECTION WAS FOUND IN THE WOUND. ON THE 6TH DAY AFTER SURGERY, A FOLLOW-UP EXAMINATION REVEALED HYPERPLASIA OF THE TWO SUTURES IN THE MIDDLE, INFLAMMATION, REDNESS AND SWELLING OF THE SKIN, AND PROLONGED SUTURING TIME. THE DOCTOR REMOVED THE SUTURES AND APPLIED TOBRAMYCIN DEXAMETHASONE EYE OINTMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Impaired Healing; Inflammation; Swelling/ Edema

  MAUDE report 24072305 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. DOCTOR REPORTED THAT THE BATCH OF SUTURE BODIES NO LONGER HAD THE SAME TOUGHNESS AS BEFORE, AND THEY OFTEN BROKE UNDER THE SAME FORCE AS BEFORE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926944 ↗
• MalfunctionDec 18, 2025Break; Device Contaminated During Manufacture or Shipping; Break; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A STRABISMUS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. ACCORDING TO THE DOCTOR'S FEEDBACK, UNDER THE MICROSCOPE, THE SUTURE IS VERY ROUGH, IN A FLOWERING STATE, AND NOT SMOOTH. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23842434 ↗
• MalfunctionDec 18, 2025Device Contaminated During Manufacture or Shipping; Material Integrity Problem; Device Contaminated During Manufacture or Shipping; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A STRABISMUS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. ACCORDING TO THE DOCTOR'S FEEDBACK, UNDER THE MICROSCOPE, THE SUTURE IS VERY ROUGH, IN A FLOWERING STATE, AND NOT SMOOTH. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23842306 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A STRABISMUS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. DOCTOR REPORTED THAT THE BATCH OF SUTURE BODIES NO LONGER HAD THE SAME TOUGHNESS AS BEFORE, AND THEY OFTEN BROKE UNDER THE SAME FORCE AS BEFORE. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838706 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A STRABISMUS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. DOCTOR REPORTED THAT THE BATCH OF SUTURE BODIES NO LONGER HAD THE SAME TOUGHNESS AS BEFORE, AND THEY OFTEN BROKE UNDER THE SAME FORCE AS BEFORE. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838675 ↗
• MalfunctionDec 18, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A STRABISMUS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. MULTIPLE SEGMENTS OF THE SUTURE CONTAINED WHITE WAX LIKE SUBSTANCES AND COULD NOT BE USED. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838503 ↗
• MalfunctionDec 18, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A STRABISMUS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. MULTIPLE SEGMENTS OF THE SUTURE CONTAINED WHITE WAX LIKE SUBSTANCES AND COULD NOT BE USED. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838500 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022269, K183183. One submission often covers many models, so check the product and lot details in each record.

• Z-1513-2025 · Mar 7, 2025 · Open, Classified
  PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP
• Z-0319-2025 · Sep 25, 2024 · Open, Classified
  Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
• Z-2144-2024 · May 10, 2024 · Open, Classified
  VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and
• Z-2146-2024 · May 10, 2024 · Open, Classified
  PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery.
• Z-0989-2020 · Jan 3, 2020 · Terminated
  Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
• Z-1087-06 · May 4, 2006 · Terminated
  Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gyc