Coated VICRYL J490GRecalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 10705031040441), received between Mar 3, 2021 and Apr 25, 2025 — classified as 67 malfunctions.

The most frequently reported specific device problem is “Material Separation” (53 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 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IN MID SURGERY, THE NEEDLE DETACHED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21908742 ↗
• MalfunctionFeb 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THEY HAD JUST OPENED A NEW BOX OF SUTURE FOR A DENTAL APPOINTMENT A WEEK TO TWO WEEKS AGO. UNFORTUNATELY, THE SUTURES SEEMED TO BREAK OFF FROM THE NEEDLE AND THEN BECAME UNUSABLE. THEY BROKE 7 OUT OF THE 12 SUTURES IN THIS BOX. SHE ONLY HAD 3 SUTURES LEFT OUT OF THIS BOX SO THEY WERE ONLY ABLE TO USE 2 SUTURES SUCCESSFULLY. THE PATIENT DID NOT HAVE ANY ADVERSE REACTION TO THE SUTURE. THE DATE WE NOTICED WAS (B)(6) 2025 WE BROKE 6 THAT DAY AND WE BROKE ONE SUTURE ON (B)(6) 2025. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21431963 ↗
• MalfunctionFeb 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THEY HAD JUST OPENED A NEW BOX OF SUTURE FOR A DENTAL APPOINTMENT A WEEK TO TWO WEEKS AGO. UNFORTUNATELY, THE SUTURES SEEMED TO BREAK OFF FROM THE NEEDLE AND THEN BECAME UNUSABLE. THEY BROKE 7 OUT OF THE 12 SUTURES IN THIS BOX. SHE ONLY HAD 3 SUTURES LEFT OUT OF THIS BOX SO THEY WERE ONLY ABLE TO USE 2 SUTURES SUCCESSFULLY. THE PATIENT DID NOT HAVE ANY ADVERSE REACTION TO THE SUTURE. THE DATE WE NOTICED WAS (B)(6) 2025 WE BROKE 6 THAT DAY AND WE BROKE ONE SUTURE ON (B)(6) 2025. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21431962 ↗
• MalfunctionFeb 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THEY HAD JUST OPENED A NEW BOX OF SUTURE FOR A DENTAL APPOINTMENT A WEEK TO TWO WEEKS AGO. UNFORTUNATELY THE SUTURES SEEMED TO BREAK OFF FROM THE NEEDLE AND THEN BECAME UNUSABLE. THEY BROKE 7 OUT OF THE 12 SUTURES IN THIS BOX. SHE ONLY HAD 3 SUTURES LEFT OUT OF THIS BOX SO THEY WERE ONLY ABLE TO USE 2 SUTURES SUCCESSFULLY. THE PATIENT DID NOT HAVE ANY ADVERSE REACTION TO THE SUTURE. THE DATE WE NOTICED WAS (B)(6) 2025 WE BROKE 6 THAT DAY AND WE BROKE ONE SUTURE ON (B)(6) 2025. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21431960 ↗
• MalfunctionFeb 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THEY HAD JUST OPENED A NEW BOX OF SUTURE FOR A DENTAL APPOINTMENT A WEEK TO TWO WEEKS AGO. UNFORTUNATELY THE SUTURES SEEMED TO BREAK OFF FROM THE NEEDLE AND THEN BECAME UNUSABLE. THEY BROKE 7 OUT OF THE 12 SUTURES IN THIS BOX. SHE ONLY HAD 3 SUTURES LEFT OUT OF THIS BOX SO THEY WERE ONLY ABLE TO USE 2 SUTURES SUCCESSFULLY. THE PATIENT DID NOT HAVE ANY ADVERSE REACTION TO THE SUTURE. THE DATE WE NOTICED WAS 1-14-25 WE BROKE 6 THAT DAY AND WE BROKE ONE SUTURE ON 1-21-25. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21431959 ↗
• MalfunctionFeb 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THEY HAD JUST OPENED A NEW BOX OF SUTURE FOR A DENTAL APPOINTMENT A WEEK TO TWO WEEKS AGO. UNFORTUNATELY THE SUTURES SEEMED TO BREAK OFF FROM THE NEEDLE AND THEN BECAME UNUSABLE. THEY BROKE 7 OUT OF THE 12 SUTURES IN THIS BOX. SHE ONLY HAD 3 SUTURES LEFT OUT OF THIS BOX SO THEY WERE ONLY ABLE TO USE 2 SUTURES SUCCESSFULLY. THE PATIENT DID NOT HAVE ANY ADVERSE REACTION TO THE SUTURE. THE DATE WE NOTICED WAS 1-14-25 WE BROKE 6 THAT DAY AND WE BROKE ONE SUTURE ON (B)(6)2025. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21431958 ↗
• MalfunctionFeb 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THEY HAD JUST OPENED A NEW BOX OF SUTURE FOR A DENTAL APPOINTMENT A WEEK TO TWO WEEKS AGO. UNFORTUNATELY, THE SUTURES SEEMED TO BREAK OFF FROM THE NEEDLE AND THEN BECAME UNUSABLE. THEY BROKE 7 OUT OF THE 12 SUTURES IN THIS BOX. SHE ONLY HAD 3 SUTURES LEFT OUT OF THIS BOX SO THEY WERE ONLY ABLE TO USE 2 SUTURES SUCCESSFULLY. THE PATIENT DID NOT HAVE ANY ADVERSE REACTION TO THE SUTURE. THE DATE WE NOTICED WAS (B)(6)2025 WE BROKE 6 THAT DAY AND WE BROKE ONE SUTURE ON (B)(6)2025. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21431957 ↗
• MalfunctionFeb 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THEY HAD JUST OPENED A NEW BOX OF SUTURE FOR A DENTAL APPOINTMENT A WEEK TO TWO WEEKS AGO. UNFORTUNATELY THE SUTURES SEEMED TO BREAK OFF FROM THE NEEDLE AND THEN BECAME UNUSABLE. THEY BROKE 7 OUT OF THE 12 SUTURES IN THIS BOX. SHE ONLY HAD 3 SUTURES LEFT OUT OF THIS BOX SO THEY WERE ONLY ABLE TO USE 2 SUTURES SUCCESSFULLY. THE PATIENT DID NOT HAVE ANY ADVERSE REACTION TO THE SUTURE. THE DATE WE NOTICED WAS 1-14-25 WE BROKE 6 THAT DAY AND WE BROKE ONE SUTURE ON 1-21-25. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21431956 ↗
• MalfunctionFeb 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON THAT WHILE DEVICE WAS IN USE, THE SUTURE POPPED OFF FROM THE NEEDLE. THIS RESULTED IN THE NEED TO GRAB ANOTHER SUTURE. THIS IS THE SAME SUTURE CODE AND LOT NUMBER FROM PREVIOUS CUSTOMER COMPLAINT. ONE DEVICE RETURNING. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21370342 ↗
• MalfunctionJan 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. A SUTURE HAD POPPED OFF DURING USE ON THE PATIENT. THE NURSE WAS NOT ON SITE TO RECOVER SUTURE, BUT THEY WILL BAG THE SUTURE AND NEEDLE IF IT HAPPENS AGAIN. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21116717 ↗
• MalfunctionJan 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. A SUTURE HAD POPPED OFF DURING USE ON THE PATIENT. THE NURSE WAS NOT ON SITE TO RECOVER SUTURE, BUT THEY WILL BAG THE SUTURE AND NEEDLE IF IT HAPPENS AGAIN. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21116460 ↗
• MalfunctionJan 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. A SUTURE HAD POPPED OFF DURING USE ON THE PATIENT. THE NURSE WAS NOT ON SITE TO RECOVER SUTURE, BUT THEY WILL BAG THE SUTURE AND NEEDLE IF IT HAPPENS AGAIN. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21116117 ↗
• MalfunctionNov 15, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A MOHS CLOSURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. USED ON THE FACE, THE DOCTOR WAS USING THE SUTURE AND THE SUTURE KEPT SLIPPING OUT OF THE NEEDLE. HAD A SMALL DELAY IN CASE BUT WERE ABLE TO COMPLETE BY USING A SUTURE FROM ANOTHER LOT AND BOX. NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694776 ↗
• MalfunctionNov 15, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A MOHS CLOSURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. USED ON THE FACE, THE DOCTOR WAS USING THE SUTURE AND THE SUTURE KEPT SLIPPING OUT OF THE NEEDLE. HAD A SMALL DELAY IN CASE BUT WERE ABLE TO COMPLETE BY USING A SUTURE FROM ANOTHER LOT AND BOX. NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694720 ↗
• MalfunctionNov 15, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A MOHS CLOSURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. USED ON THE FACE, THE DOCTOR WAS USING THE SUTURE AND THE SUTURE KEPT SLIPPING OUT OF THE NEEDLE. HAD A SMALL DELAY IN CASE BUT WERE ABLE TO COMPLETE BY USING A SUTURE FROM ANOTHER LOT AND BOX. NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694699 ↗
• MalfunctionJun 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE FALLS OFF THE NEEDLE WHEN THEY GO TO USE IT, THAT IT IS NOT SWAGED ON FULLY. THEY HAVE TRIED 5 PACKS AND EACH TIME THE SUTURE JUST FALLS RIGHT OFF FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19609841 ↗
• MalfunctionJun 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE FALLS OFF THE NEEDLE WHEN THEY GO TO USE IT, THAT IT IS NOT SWAGED ON FULLY. THEY HAVE TRIED 5 PACKS AND EACH TIME THE SUTURE JUST FALLS RIGHT OFF FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19609323 ↗
• MalfunctionJun 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE FALLS OFF THE NEEDLE WHEN THEY GO TO USE IT, THAT IT IS NOT SWAGED ON FULLY. THEY HAVE TRIED 5 PACKS AND EACH TIME THE SUTURE JUST FALLS RIGHT OFF FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19609109 ↗
• MalfunctionJun 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE FALLS OFF THE NEEDLE WHEN THEY GO TO USE IT, THAT IT IS NOT SWAGED ON FULLY. THEY HAVE TRIED 5 PACKS AND EACH TIME THE SUTURE JUST FALLS RIGHT OFF FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19609015 ↗
• MalfunctionJun 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE FALLS OFF THE NEEDLE WHEN THEY GO TO USE IT, THAT IT IS NOT SWAGED ON FULLY. THEY HAVE TRIED 5 PACKS AND EACH TIME THE SUTURE JUST FALLS RIGHT OFF FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19608965 ↗
• MalfunctionApr 22, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL SURGERY ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS COMING UNDONE WHILE SUTURING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19156040 ↗
• MalfunctionApr 22, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL SURGERY ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS COMING UNDONE WHILE SUTURING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154918 ↗
• MalfunctionApr 22, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL SURGERY ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS COMING UNDONE WHILE SUTURING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154908 ↗
• MalfunctionApr 22, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL SURGERY ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS COMING UNDONE WHILE SUTURING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154907 ↗
• MalfunctionApr 19, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT A GENERAL SURGERY PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. THE SWAGED VICRYL CODE IS PERFORMING LIKE A CONTROL-RELEASE; THE NEEDLE IS POPPING OFF. NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19144019 ↗

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