Coated VICRYL J566GRecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10705031041264), received between Apr 6, 2020 and Jul 27, 2026 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Break” (24 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50008369 ↗
• MalfunctionJul 27, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50008357 ↗
• MalfunctionJul 27, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50008135 ↗
• MalfunctionJul 27, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50008124 ↗
• MalfunctionAug 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE WAS DETACHED FROM THE NEEDLE SEVERAL TIMES. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THE FACILITY HAS REQUESTED TO EXCHANGE ONE BOX FOR A NEW ONE IF POSSIBLE. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22887282 ↗
• MalfunctionAug 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE WAS DETACHED FROM THE NEEDLE SEVERAL TIMES. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THE FACILITY HAS REQUESTED TO EXCHANGE ONE BOX FOR A NEW ONE IF POSSIBLE. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22887281 ↗
• MalfunctionAug 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE WAS DETACHED FROM THE NEEDLE SEVERAL TIMES. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THE FACILITY HAS REQUESTED TO EXCHANGE ONE BOX FOR A NEW ONE IF POSSIBLE. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22887279 ↗
• MalfunctionAug 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE WAS DETACHED FROM THE NEEDLE SEVERAL TIMES. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THE FACILITY HAS REQUESTED TO EXCHANGE ONE BOX FOR A NEW ONE IF POSSIBLE. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22887277 ↗
• MalfunctionMar 12, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THIS KEEPS SNAPPING WHEN BEING USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583857 ↗
• MalfunctionMar 12, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THIS KEEPS SNAPPING WHEN BEING USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583856 ↗
• MalfunctionFeb 26, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE, AND SUTURE WAS USED. AFTER OPENING THE PACKAGE AND BEFORE USE, IT WAS FOUND THAT THE NEEDLE HAD BEEN BROKEN AT THE BODY PART. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HEALTHCARE PROVIDER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778917 ↗
• MalfunctionFeb 26, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE, AND SUTURE WAS USED. AFTER OPENING THE PACKAGE AND BEFORE USE, IT WAS FOUND THAT THE NEEDLE HAD BEEN BROKEN AT THE BODY PART. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HEALTHCARE PROVIDER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778913 ↗
• MalfunctionFeb 26, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE, AND SUTURE WAS USED. AFTER OPENING THE PACKAGE AND BEFORE USE, IT WAS FOUND THAT THE NEEDLE HAD BEEN BROKEN AT THE BODY PART. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HEALTHCARE PROVIDER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778912 ↗
• MalfunctionFeb 26, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE, AND SUTURE WAS USED. AFTER OPENING THE PACKAGE AND BEFORE USE, IT WAS FOUND THAT THE NEEDLE HAD BEEN BROKEN AT THE BODY PART. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HEALTHCARE PROVIDER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778895 ↗
• MalfunctionDec 7, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PENILE ADHESION LYSIS, CIRCUMCISION, PENILE CHORDEE CORRECTION, AND SCROTOPLASTY PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DOCTOR HAS COMPLAINED OF WOUND DEHISCENCES HAPPENING WITH THE 7-0 SUTURE. HE HAS HAD SOME SUTURE BREAKING WHILE KNOT TYING. DURING A PENILE ADHESION LYSIS, CIRCUMCISION, PENILE CHORDEE CORRECTION, AND SCROTOPLASTY. TWO SEPARATE SUTURES BROKE DURING KNOT TYING. THE SUTURE IS FROM THE SAME BOX AND LOT NUMBER. UNKNOWN HOW MANY MINUTES THE SURGERY WAS DELAYED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15936298 ↗
• MalfunctionDec 7, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PENILE ADHESION LYSIS, CIRCUMCISION, PENILE CHORDEE CORRECTION AND SCROTOPLASTY PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DOCTOR HAS COMPLAINED OF WOUND DEHISCENCES HAPPENING WITH THE 7-0 SUTURE. HE HAS HAD SOME SUTURE BREAKING WHILE KNOT TYING. DURING A PENILE ADHESION LYSIS, CIRCUMCISION, PENILE CHORDEE CORRECTION, AND SCROTOPLASTY. TWO SEPARATE SUTURES BROKE DURING KNOT TYING. THE SUTURE IS FROM THE SAME BOX AND LOT NUMBER. UNKNOWN HOW MANY MINUTES THE SURGERY WAS DELAYED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 15936211 ↗
• MalfunctionMar 12, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGICAL PROCEDURE IN (B)(6)2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11474690 ↗
• MalfunctionMar 11, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGICAL PROCEDURE (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11466759 ↗
• MalfunctionMar 11, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGICAL PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11466497 ↗
• MalfunctionMar 11, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGICAL PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11464180 ↗
• MalfunctionMar 11, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGICAL PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11464172 ↗
• MalfunctionMar 11, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGICAL PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11464163 ↗
• MalfunctionMar 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGY PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A PEDIATRIC UROLOGY PROCEDURE TWO SUTURES BROKE. A THIRD SUTURE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11399811 ↗
• MalfunctionMar 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGY PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A PEDIATRIC UROLOGY PROCEDURE TWO SUTURES BROKE. A THIRD SUTURE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11399781 ↗
• MalfunctionFeb 12, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UROLOGY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER DEVICE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11321347 ↗

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