Coated VICRYL JJ31GRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031044111), received between Apr 8, 2020 and Sep 10, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL HYSTERECTOMY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, BIOBURDEN WAS FOUND ON SUTURE UPON OPENING. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23018681 ↗
• MalfunctionMar 20, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE DOCTOR WAS CONCERNED ABOUT ONE OF THE SUTURE PACKS. HE THOUGHT ONE OF HIS 0 POP-OFF SUTURE PACKS WERE TOO THIN FOR IT BEING A 0 SUTURE. DEVICES WERE RETURNING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21654158 ↗
• MalfunctionMar 20, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE DOCTOR WAS CONCERNED ABOUT ONE OF THE SUTURE PACKS. HE THOUGHT ONE OF HIS 0 POP-OFF SUTURE PACKS WERE TOO THIN FOR IT BEING A 0 SUTURE. DEVICES WERE RETURNING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21654157 ↗
• MalfunctionMar 20, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE DOCTOR WAS CONCERNED ABOUT ONE OF THE SUTURE PACKS. HE THOUGHT ONE OF HIS 0 POP-OFF SUTURE PACKS WERE TOO THIN FOR IT BEING A 0 SUTURE. DEVICES WERE RETURNING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21654155 ↗
• MalfunctionNov 22, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYN PROCEDURE ON 10/27/2023, AND SUTURE WAS USED. THE SURGEON WAS PASSING SUTURE THROUGH TISSUE, RIGHT URETEROSACRAL, AND THE SUTURE NEEDLE BROKE IN HALF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER A NEW SUTURE WAS OPENED. THERE WAS NO SURGERY DELAY DUE TO THE REPORTED EVENT. FRAGMENTS WERE GENERATED BUT WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18192263 ↗
• MalfunctionApr 8, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PARTIAL HYSTERECTOMY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE DETACHED/BROKE OFF FROM THE NEEDLE DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9941893 ↗
• MalfunctionApr 8, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PARTIAL HYSTERECTOMY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE DETACHED FROM NEEDLE DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9941803 ↗
• MalfunctionApr 8, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PARTIAL HYSTERECTOMY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE DETACHED/BROKE OFF FROM THE NEEDLE DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9941758 ↗
• MalfunctionApr 8, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PARTIAL HYSTERECTOMY ON (B)(6) 2020 AND THE SUTURE WAS USED. DURING THE SURGERY, THE SUTURE DETACHED/BROKE OFF FROM THE NEEDLE DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9941753 ↗

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