Coated VICRYL J215HRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10705031038240), received between Apr 5, 2021 and Dec 5, 2024 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Material Separation” (26 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING SUTURING, EXPERIENCED THAT 2 SUTURE WERE EASY TO BREAK WHEN PULLING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854064 ↗
• MalfunctionDec 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING SUTURING, EXPERIENCED THAT 2 SUTURE WERE EASY TO BREAK WHEN PULLING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854048 ↗
• MalfunctionApr 23, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HERNIA REPAIR SURGERY ON THE 15TH OF AN UNKNOWN MONTH IN 2024 AND SUTURE WAS USED. THE SUTURE STRAND BROKE DURING THE SURGERY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19162909 ↗
• MalfunctionMar 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PEDIATRIC EAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLES WERE POPPING OFF AND SEPARATING FROM THE SUTURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18980017 ↗
• MalfunctionMar 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PEDIATRIC EAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLES WERE POPPING OFF AND SEPARATING FROM THE SUTURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18980006 ↗
• MalfunctionMar 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. THE SUTURE WAS DISCONNECTING FROM THE NEEDLE AND NOT STAYING ATTACHED ONCE THE SURGEON STARTED USING IT. THERE WAS NO PATIENT HARM REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18870726 ↗
• MalfunctionMar 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DISCONNECTING FROM THE NEEDLE AND NOT STAYING ATTACHED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18869755 ↗
• MalfunctionMar 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. THERE WAS AN ISSUE WITH THE SUTURE POPPING OFF THE NEEDLE. NO PATIENT CONSEQUENCE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18864255 ↗
• MalfunctionMar 6, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT; DURING SURGICAL PROCEDURES, THE NEEDLES ARE FALLING OFF. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THE DEVICE IS AVAILABLE FOR RETURN.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18848769 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING SURGICAL PROCEDURE, THE NEEDLE FALLING OFF. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841654 ↗
• MalfunctionFeb 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PEDIATRIC EAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLES WERE POPPING OFF AND SEPARATING FROM THE SUTURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639800 ↗
• MalfunctionFeb 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PEDIATRIC EAR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLES WERE POPPING OFF AND SEPARATING FROM THE SUTURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639797 ↗
• MalfunctionDec 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE NEEDLES KEPT POPPING OFF THE SUTURE. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18253068 ↗
• MalfunctionDec 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE NEEDLES KEPT POPPING OFF THE SUTURE. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18253067 ↗
• MalfunctionDec 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE NEEDLES KEPT POPPING OFF THE SUTURE. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18253024 ↗
• MalfunctionDec 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE NEEDLES KEPT POPPING OFF THE SUTURE. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18253022 ↗
• MalfunctionDec 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE NEEDLES KEPT POPPING OFF THE SUTURE. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18253017 ↗
• MalfunctionDec 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE NEEDLES KEPT POPPING OFF THE SUTURE. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18253014 ↗
• MalfunctionDec 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE NEEDLES KEPT POPPING OFF THE SUTURE. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18252934 ↗
• MalfunctionDec 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE NEEDLES KEPT POPPING OFF THE SUTURE. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18252849 ↗
• MalfunctionDec 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE NEEDLES KEPT POPPING OFF THE SUTURE. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18252847 ↗
• MalfunctionDec 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE NEEDLES KEPT POPPING OFF THE SUTURE. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18252814 ↗
• MalfunctionNov 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, A SURGEON STRUGGLED WITH SUTURE ON AN RB-1 RUNNING AS THE NEEDLE KEPT POPPING OFF. THEY USED FIVE PACKAGES FROM THE SAME BOX, ALL WITH THE SAME RESULT. THE SURGEON FINALLY CHANGED SUTURE TO COMPLETE THE CASE. THE PATIENT EXPERIENCED A LONGER TIME UNDER ANESTHESIA WHILE THEY STRUGGLED WITH SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18151267 ↗
• MalfunctionNov 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, A SURGEON STRUGGLED WITH SUTURE ON AN RB-1 RUNNING AS THE NEEDLE KEPT POPPING OFF. THEY USED FIVE PACKAGES FROM THE SAME BOX, ALL WITH THE SAME RESULT. THE SURGEON FINALLY CHANGED SUTURE TO COMPLETE THE CASE. THE PATIENT EXPERIENCED A LONGER TIME UNDER ANESTHESIA WHILE THEY STRUGGLED WITH SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18150319 ↗
• MalfunctionNov 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 20-OCT-2023 AND SUTURE WAS USED. DURING THE PROCEDURE, A SURGEON STRUGGLED WITH SUTURE ON AN RB-1 RUNNING AS THE NEEDLE KEPT POPPING OFF. THEY USED FIVE PACKAGES FROM THE SAME BOX, ALL WITH THE SAME RESULT. THE SURGEON FINALLY CHANGED SUTURE TO COMPLETE THE CASE. THE PATIENT EXPERIENCED A LONGER TIME UNDER ANESTHESIA WHILE THEY STRUGGLED WITH SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18150318 ↗

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