Coated VICRYL J556GRecalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10705031041233), received between Oct 22, 2018 and Apr 2, 2026 — classified as 7 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT DURING PEDIATRIC ANASTOMOSIS URETER THE SUTURE BROKE. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766024 ↗
• MalfunctionMar 25, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRE-OP, THE NURSES NOTICED THAT THERE SEEMED TO BE AIR IN THE PACKAGING OF SOME OF THE SUTURES. THE PACKAGING IS BULGING. HOWEVER, NOT ALL THE SUTURES FROM THE SAME BOX SEEMED TO BE AFFECTED. THEY ARE A PEDIATRIC CLINIC AND THEY DIDN'T WANT TO TAKE ANY CHANCES WITH STERILITY, SO THEY USED OTHER SUTURES FROM ANOTHER BATCH LOT. I HAVE A FULL BOX TO RETURN (12 UNITS). PLEASE CREDIT 1 BOX. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO SIGNIFICANT DELAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24694320 ↗
• MalfunctionMar 25, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRE-OP, THE NURSES NOTICED THAT THERE SEEMED TO BE AIR IN THE PACKAGING OF SOME OF THE SUTURES. THE PACKAGING IS BULGING. HOWEVER, NOT ALL THE SUTURES FROM THE SAME BOX SEEMED TO BE AFFECTED. THEY ARE A PEDIATRIC CLINIC AND THEY DIDN'T WANT TO TAKE ANY CHANCES WITH STERILITY, SO THEY USED OTHER SUTURES FROM ANOTHER BATCH LOT. I HAVE A FULL BOX TO RETURN (12 UNITS). PLEASE CREDIT 1 BOX. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO SIGNIFICANT DELAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24694317 ↗
• MalfunctionMar 25, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRE-OP, THE NURSES NOTICED THAT THERE SEEMED TO BE AIR IN THE PACKAGING OF SOME OF THE SUTURES. THE PACKAGING IS BULGING. HOWEVER, NOT ALL THE SUTURES FROM THE SAME BOX SEEMED TO BE AFFECTED. THEY ARE A PEDIATRIC CLINIC AND THEY DIDN'T WANT TO TAKE ANY CHANCES WITH STERILITY, SO THEY USED OTHER SUTURES FROM ANOTHER BATCH LOT. I HAVE A FULL BOX TO RETURN (12 UNITS). PLEASE CREDIT 1 BOX. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO SIGNIFICANT DELAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24694316 ↗
• MalfunctionMar 25, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRE-OP, THE NURSES NOTICED THAT THERE SEEMED TO BE AIR IN THE PACKAGING OF SOME OF THE SUTURES. THE PACKAGING IS BULGING. HOWEVER, NOT ALL THE SUTURES FROM THE SAME BOX SEEMED TO BE AFFECTED. THEY ARE A PEDIATRIC CLINIC AND THEY DIDN'T WANT TO TAKE ANY CHANCES WITH STERILITY, SO THEY USED OTHER SUTURES FROM ANOTHER BATCH LOT. I HAVE A FULL BOX TO RETURN (12 UNITS). PLEASE CREDIT 1 BOX. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO SIGNIFICANT DELAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24694315 ↗
• MalfunctionMar 25, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRE-OP, THE NURSES NOTICED THAT THERE SEEMED TO BE AIR IN THE PACKAGING OF SOME OF THE SUTURES. THE PACKAGING IS BULGING. HOWEVER, NOT ALL THE SUTURES FROM THE SAME BOX SEEMED TO BE AFFECTED. THEY ARE A PEDIATRIC CLINIC AND THEY DIDN'T WANT TO TAKE ANY CHANCES WITH STERILITY, SO THEY USED OTHER SUTURES FROM ANOTHER BATCH LOT. I HAVE A FULL BOX TO RETURN (12 UNITS). PLEASE CREDIT 1 BOX. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO SIGNIFICANT DELAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24694314 ↗
• MalfunctionMar 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A STRABISMUS PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SURGEON WAS PERFORMING A STRABISMUS REPAIR. AFTER IMBRICATION OF THE MUSCLE, UPON TYING THE SUTURE TO THE SCLERA, THE SUTURE BROKE IN THE MUSCULAR PORTION OF THE SUTURE. THERE WAS NOT ANY EXCESSIVE TENSION ON THE SUTURE OR MUSCLE, NOR HAD THE SUTURE BEEN WEAKENED FROM CAUTERY. THERE WAS CONCERN THAT THE SUTURE WAS DEFECTIVE. THIS LED TO NEEDING TO RE-IMBRICATE THE MUSCLE, ADDING AN ADDITIONAL 10-15 MINUTES TO OPERATIVE TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537390 ↗
• MalfunctionJul 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE OFF FROM THE SUTURE DURING SURGERY. NO ADVERSE IMPACT TO PATIENT/USER WAS REPORTED. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373382 ↗
• MalfunctionJul 1, 2025Material Separation; Dull, Blunt; Material Separation; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE SECOND SURGERY THE SUTURE CAME OFF THE NEEDLE AND DID NOT PASS THROUGH THE MUSCLE. NO ADVERSE IMPACT TO PATIENT/USER WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371699 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT DEVELOPED AN INFLAMMATORY REACTION TO THE EYE SUTURE. PATIENT REQUIRED STEROIDS AND ANTIBIOTICS TO RESOLVE THE ISSUE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 22091339 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT DEVELOPED AN INFLAMMATORY REACTION TO THE EYE SUTURE. PATIENT REQUIRED STEROIDS AND ANTIBIOTICS TO RESOLVE THE ISSUE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Local Reaction; Unspecified Infection

  MAUDE report 22091313 ↗
• MalfunctionAug 15, 2024Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP IS REPORTING THAT THE SUTURE WAS BREAKING AND FRAYING AT THE MID-WAY POINT OF THE SUTURE. THE SECOND ONE FRAYED/BROKE AS WELL AND THE THIRD ONE COMPLETELY DURING THE EYE PROCEDURE WHEN TRYING TO PULL THE SUTURE THROUGH THE MUSCLE. THEY WERE ABLE TO GET ONE THAT WORKED TO COMPLETE THE CASE WITHOUT PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991016 ↗
• MalfunctionAug 15, 2024Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP IS REPORTING THAT THE SUTURE WAS BREAKING AND FRAYING AT THE MID-WAY POINT OF THE SUTURE. THE SECOND ONE FRAYED/BROKE AS WELL AND THE THIRD ONE COMPLETELY DURING THE EYE PROCEDURE WHEN TRYING TO PULL THE SUTURE THROUGH THE MUSCLE. THEY WERE ABLE TO GET ONE THAT WORKED TO COMPLETE THE CASE WITHOUT PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991002 ↗
• MalfunctionAug 15, 2024Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP IS REPORTING THAT THE SUTURE WAS BREAKING AND FRAYING AT THE MID-WAY POINT OF THE SUTURE. THE SECOND ONE FRAYED/BROKE AS WELL AND THE THIRD ONE COMPLETELY DURING THE EYE PROCEDURE WHEN TRYING TO PULL THE SUTURE THROUGH THE MUSCLE. THEY WERE ABLE TO GET ONE THAT WORKED TO COMPLETE THE CASE WITHOUT PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991000 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE ON THE EYE AND SUTURE WAS USED. POST-OP, THE PATIENT PRESENTED WITH INFLAMMATION. THE SURGEON PRESCRIBED STEROIDS TO CONTROL THE INFLAMMATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma; Inflammation

  MAUDE report 18714753 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE ON THE EYE AND SUTURE WAS USED. POST-OP, THE PATIENT PRESENTED WITH INFLAMMATION. THE SURGEON PRESCRIBED STEROIDS TO CONTROL THE INFLAMMATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation

  MAUDE report 18714748 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE ON THE EYE AND SUTURE WAS USED. POST-OP, THE PATIENT PRESENTED WITH INFLAMMATION. THE SURGEON PRESCRIBED STEROIDS TO CONTROL THE INFLAMMATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma; Inflammation

  MAUDE report 18714723 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE ON THE EYE AND SUTURE WAS USED. POST-OP, THE PATIENT PRESENTED WITH INFLAMMATION. THE SURGEON PRESCRIBED STEROIDS TO CONTROL THE INFLAMMATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation

  MAUDE report 18714719 ↗
• MalfunctionAug 29, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES KEEP POPPING OFF WHEN TRYING TO GRASP IT AND WITH MINIMAL MANIPULATION AND FORCE. 15 SAMPLES WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643385 ↗
• MalfunctionAug 29, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES KEEP POPPING OFF WHEN TRYING TO GRASP IT AND WITH MINIMAL MANIPULATION AND FORCE. 15 SAMPLES WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643384 ↗
• MalfunctionApr 14, 2023Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. WHILE USING THE DEVICE ON THE PATIENT, EVERY TIME THEY TRY TO PUT A KNOT IN THE SUTURE, IT FRAYS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742639 ↗
• MalfunctionApr 14, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. WHILE USING THE DEVICE ON THE PATIENT, EVERY TIME THEY TRY TO PUT A KNOT IN THE SUTURE, IT FRAYS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742638 ↗
• MalfunctionApr 14, 2023Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. WHILE USING THE DEVICE ON THE PATIENT, EVERY TIME THEY TRY TO PUT A KNOT IN THE SUTURE, IT FRAYS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742637 ↗
• MalfunctionApr 14, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. WHILE USING THE DEVICE ON THE PATIENT, EVERY TIME THEY TRY TO PUT A KNOT IN THE SUTURE, IT FRAYS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742631 ↗
• MalfunctionMar 3, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A STRABISMUS SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN TYING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16477556 ↗

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-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-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-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