Coated VICRYL J575GRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031041370), received between Jun 17, 2021 and Aug 5, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 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 THEY USE THE SUTURE FOR CONJUNCTIVA. IN THE OR THEY HAD THE NEEDLE JUST 'FALL' OFF THE SUTURE WHILE THE SCRUB TECH WAS PICKING IT UP. THEY MANAGED TO FIND IT (THOSE NEEDLES ARE SMALL- ESPECIALLY WITH NO SUTURE ATTACHED TO IT). THIS IS THE 2ND TIME THIS HAS HAPPENED TO THEM, WITH THE SAME SUTURE, BUT DIFFERENT SCRUB TECHS EACH TIME. THEY DON'T HAVE THE LOT FROM THE PREVIOUS INCIDENT (ABOUT A MONTH AGO)- AS THAT WAS THE FIRST TIME IT HAPPENED. THEY DIDN'T SAVE THE PACKAGING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714713 ↗
• MalfunctionAug 5, 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 THEY USE THE SUTURE FOR CONJUNCTIVA. IN THE OR THEY HAD THE NEEDLE JUST 'FALL' OFF THE SUTURE WHILE THE SCRUB TECH WAS PICKING IT UP. THEY MANAGED TO FIND IT (THOSE NEEDLES ARE SMALL- ESPECIALLY WITH NO SUTURE ATTACHED TO IT). THIS IS THE 2ND TIME THIS HAS HAPPENED TO THEM, WITH THE SAME SUTURE, BUT DIFFERENT SCRUB TECHS EACH TIME. THEY DON'T HAVE THE LOT FROM THE PREVIOUS INCIDENT (ABOUT A MONTH AGO)- AS THAT WAS THE FIRST TIME IT HAPPENED. THEY DIDN'T SAVE THE PACKAGING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714709 ↗
• MalfunctionJun 17, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12016479 ↗

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