Coated VICRYL J492GRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031040465), received between Aug 12, 2021 and Jul 15, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 reports).

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

• MalfunctionJul 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT PROVIDER WAS ATTEMPTING TO STITCH PATIENT'S LACERATION ON FOREHEAD WITH 6-0 VICRYL. WHILE SO DOING, THE THREAD UNRAVELED. HE CUT OFF THE NEEDLE, WHICH TEMPORARILY COULDN'T FIND, BUT DID SHORTLY UNDER THE STERILE DRAPE. ANOTHER PACKAGE OF SUTURING MATERIAL WAS OBTAINED WHICH WORKED FINE, AND THE LAC WAS REPAIRED. THE ISSUE WAS THE THREAD UNRAVELING. NO ADVERSE IMPACT TO THE PATIENT/USER WAS REPORTED. THE DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22514981 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BLEPHAROPLASTY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT DEVELOPED A POST OP ABSCESS UP TO FIVE WEEKS POST OPERATIVELY. THE ABSCESS WAS TREATED BY REMOVING THE STITCH THAT STILL REMAINED IN THE TISSUE AND ANTIBIOTICS IF NEEDED. THE PATIENT IS CURRENTLY DOING WELL.

  Patient problems: Abscess

  MAUDE report 18145223 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BLEPHAROPLASTY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT DEVELOPED A POST OP ABSCESS UP TO FIVE WEEKS POST OPERATIVELY. THE ABSCESS WAS TREATED BY REMOVING THE STITCH THAT STILL REMAINED IN THE TISSUE AND ANTIBIOTICS IF NEEDED. THE PATIENT IS CURRENTLY DOING WELL.

  Patient problems: Abscess

  MAUDE report 18145220 ↗
• MalfunctionMay 6, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE IS POPPING OFF THE SUTURE PREMATURELY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14296858 ↗
• InjurySep 23, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON UNKNOWN DATE AND THE SUTURE WAS USED UNDER EYELID. AROUND A MONTH AFTER SURGERY, THE PATIENT CAME BACK FEELING SOME FOREIGN MATERIAL UNDER THE EYELID AND EXPERIENCING BLURRED EYESIGHT. IT WAS FOUND THAT THE CORNEA WAS DAMAGED DUE TO THE PRESENCE OF SUTURE MATERIAL. THE SURGEON OPINED THAT THE ABSORPTION OF SUTURE WAS SLOWER THAN USUAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Eye Injury

  MAUDE report 12524107 ↗
• MalfunctionAug 12, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE WAS SEPARATING FORM THE THREAD. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12313854 ↗

Recalls under the same FDA submission

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

• 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