Coated VICRYL VCP500GRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10705031053854), received between Jul 21, 2019 and Apr 14, 2026 — classified as 1 injury, 27 malfunctions.

The most frequently reported specific device problem is “Material Separation” (27 reports).

2 other recalls cover devices cleared under the same FDA submission (K032420, K132580, K181652); 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WE HAD SOME ISSUES WITH SOME OF OUR SUTURES THIS MORNING DURING A UROLOGY LIST. THE SURGEON HAD X2 BROKEN SUTURES (NEEDLE PULL-OFF) DURING HIS CLOSURES. WE APPARENTLY HAD X1 OTHER OCCURRENCE OF THE SAME THING A WEEK AGO (NO-ONE TOLD ME ABOUT THAT ONE.) THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877890 ↗
• MalfunctionApr 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. WE HAD SOME ISSUES WITH SOME OF OUR SUTURES THIS MORNING DURING A UROLOGY LIST. THE SURGEON HAD X2 BROKEN SUTURES (NEEDLE PULL-OFF) DURING HIS CLOSURES. WE APPARENTLY HAD X1 OTHER OCCURRENCE OF THE SAME THING A WEEK AGO (NO-ONE TOLD ME ABOUT THAT ONE.) NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877290 ↗
• MalfunctionApr 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. WE HAD SOME ISSUES WITH SOME OF OUR SUTURES THIS MORNING DURING A UROLOGY LIST. THE SURGEON HAD X2 BROKEN SUTURES (NEEDLE PULL-OFF) DURING HIS CLOSURES. WE APPARENTLY HAD X1 OTHER OCCURRENCE OF THE SAME THING A WEEK AGO (NO-ONE TOLD ME ABOUT THAT ONE.) NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877280 ↗
• MalfunctionNov 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGY PROCEDURE ON 2025 AND SUTURE WAS USED. A UROLOGY SURGEON REPORTED THAT THE NEEDLE KEEPS COMING OFF THE SUTURE DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23572625 ↗
• MalfunctionNov 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. A UROLOGY SURGEON REPORTED THAT THE NEEDLE KEEPS COMING OFF THE SUTURE DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570922 ↗
• MalfunctionNov 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. A UROLOGY SURGEON REPORTED THAT THE NEEDLE KEEPS COMING OFF THE SUTURE DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570889 ↗
• MalfunctionNov 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. A UROLOGY SURGEON REPORTED THAT THE NEEDLE KEEPS COMING OFF THE SUTURE DURING SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570349 ↗
• MalfunctionJul 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THE NEEDLE KEEPS COMING AWAY FROM THE THREAD. THE DR TRIED SUTURES FROM EACH BOX WITH THE SAME RESULT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22613011 ↗
• MalfunctionJul 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THE NEEDLE KEEPS COMING AWAY FROM THE THREAD. THE DR TRIED SUTURES FROM EACH BOX WITH THE SAME RESULT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22612790 ↗
• MalfunctionMay 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THE NEEDLE KEEPS COMING AWAY FROM THE THREAD. THE DR TRIED SUTURES FROM EACH BOX WITH THE SAME RESULT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21995750 ↗
• MalfunctionMay 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THE NEEDLE KEEPS COMING AWAY FROM THE THREAD. THE DR TRIED SUTURES FROM EACH BOX WITH THE SAME RESULT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21995749 ↗
• MalfunctionMay 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THE NEEDLE KEEPS COMING AWAY FROM THE THREAD. THE DR TRIED SUTURES FROM EACH BOX WITH THE SAME RESULT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21995744 ↗
• MalfunctionMay 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THE NEEDLE KEEPS COMING AWAY FROM THE THREAD. THE DR TRIED SUTURES FROM EACH BOX WITH THE SAME RESULT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21995741 ↗
• MalfunctionMay 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THE NEEDLE KEEPS COMING AWAY FROM THE THREAD. THE DR TRIED SUTURES FROM EACH BOX WITH THE SAME RESULT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21995737 ↗
• MalfunctionMay 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THE NEEDLE KEEPS COMING AWAY FROM THE THREAD. THE DR TRIED SUTURES FROM EACH BOX WITH THE SAME RESULT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21995685 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, I HAVE BEEN USING ETHICON VICRYL SUTURES FOR OVER 13 YEARS AND HAVE ALWAYS FOUND THEM RELIABLE AND EASY TO HANDLE. RECENTLY, WE ORDERED FOUR BOXES OF VICRYL SUTURES¿THREE FROM HENRY SCHEIN AND ONE FROM MEDIDENT. AFTER EXPERIENCING SIGNIFICANT DELIVERY DELAYS, WHICH WERE ALREADY FRUSTRATING, WE FINALLY RECEIVED OUR ORDER. HOWEVER, UPON USING THESE SUTURES IN FOUR SEPARATE SURGERIES, I HAVE NOTICED A DRASTIC DECLINE IN QUALITY THAT HAS SERIOUSLY IMPACTED MY CLINICAL PROCEDURES. THE ISSUES I HAVE ENCOUNTERED INCLUDE: NEEDLES DETACHING FROM THE THREADS REPEATEDLY. SUTURES EXHIBITING EXCESSIVE COILING, EVEN WHEN WET. INCREASED DIFFICULTY IN TYING KNOTS, WITH KNOTS FREQUENTLY COMING LOOSE. ROUGHER TEXTURE OF THE SUTURE MATERIAL COMPARED TO PREVIOUS BATCHES. THESE PROBLEMS WERE CONSISTENT ACROSS ALL FOUR BOXES, NOT LIMITED TO A SINGLE BATCH. THIS SIGNIFICANT DROP IN QUALITY HAS COMPROMISED SURGICAL EFFICIENCY, PROLONGED PROCEDURES, AND CREATED FRUSTRATION FOR BOTH MYSELF AND MY DENTAL ASSISTANT. MORE CRITICALLY, IT POSES A POTENTIAL RISK TO PATIENT OUTCOMES, PARTICULARLY IN PRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943377 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, I HAVE BEEN USING ETHICON VICRYL SUTURES FOR OVER 13 YEARS AND HAVE ALWAYS FOUND THEM RELIABLE AND EASY TO HANDLE. RECENTLY, WE ORDERED FOUR BOXES OF VICRYL SUTURES¿THREE FROM HENRY SCHEIN AND ONE FROM MEDIDENT. AFTER EXPERIENCING SIGNIFICANT DELIVERY DELAYS, WHICH WERE ALREADY FRUSTRATING, WE FINALLY RECEIVED OUR ORDER. HOWEVER, UPON USING THESE SUTURES IN FOUR SEPARATE SURGERIES, I HAVE NOTICED A DRASTIC DECLINE IN QUALITY THAT HAS SERIOUSLY IMPACTED MY CLINICAL PROCEDURES. THE ISSUES I HAVE ENCOUNTERED INCLUDE: NEEDLES DETACHING FROM THE THREADS REPEATEDLY. SUTURES EXHIBITING EXCESSIVE COILING, EVEN WHEN WET. INCREASED DIFFICULTY IN TYING KNOTS, WITH KNOTS FREQUENTLY COMING LOOSE. ROUGHER TEXTURE OF THE SUTURE MATERIAL COMPARED TO PREVIOUS BATCHES. THESE PROBLEMS WERE CONSISTENT ACROSS ALL FOUR BOXES, NOT LIMITED TO A SINGLE BATCH. THIS SIGNIFICANT DROP IN QUALITY HAS COMPROMISED SURGICAL EFFICIENCY, PROLONGED PROCEDURES, AND CREATED FRUSTRATION FOR BOTH MYSELF AND MY DENTAL ASSISTANT. MORE CRITICALLY, IT POSES A POTENTIAL RISK TO PATIENT OUTCOMES, PARTICULARLY IN PRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943376 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, I HAVE BEEN USING ETHICON VICRYL SUTURES FOR OVER 13 YEARS AND HAVE ALWAYS FOUND THEM RELIABLE AND EASY TO HANDLE. RECENTLY, WE ORDERED FOUR BOXES OF VICRYL SUTURES¿THREE FROM HENRY SCHEIN AND ONE FROM MEDIDENT. AFTER EXPERIENCING SIGNIFICANT DELIVERY DELAYS, WHICH WERE ALREADY FRUSTRATING, WE FINALLY RECEIVED OUR ORDER. HOWEVER, UPON USING THESE SUTURES IN FOUR SEPARATE SURGERIES, I HAVE NOTICED A DRASTIC DECLINE IN QUALITY THAT HAS SERIOUSLY IMPACTED MY CLINICAL PROCEDURES. THE ISSUES I HAVE ENCOUNTERED INCLUDE: NEEDLES DETACHING FROM THE THREADS REPEATEDLY. SUTURES EXHIBITING EXCESSIVE COILING, EVEN WHEN WET. INCREASED DIFFICULTY IN TYING KNOTS, WITH KNOTS FREQUENTLY COMING LOOSE. ROUGHER TEXTURE OF THE SUTURE MATERIAL COMPARED TO PREVIOUS BATCHES. THESE PROBLEMS WERE CONSISTENT ACROSS ALL FOUR BOXES, NOT LIMITED TO A SINGLE BATCH. THIS SIGNIFICANT DROP IN QUALITY HAS COMPROMISED SURGICAL EFFICIENCY, PROLONGED PROCEDURES, AND CREATED FRUSTRATION FOR BOTH MYSELF AND MY DENTAL ASSISTANT. MORE CRITICALLY, IT POSES A POTENTIAL RISK TO PATIENT OUTCOMES, PARTICULARLY IN PRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943374 ↗
• MalfunctionApr 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WE HAVE BEEN ADVISED BY OUR SUPPLIER HENRY SCHEIN TO CONTACT JOHNSON AND JOHNSON DIRECTLY REGARDING A FAULTY BOX OF SUTURES PURCHASE. THE SUTURES ARE ETHICON VICRYL 5/0 PS-3/8 16MM REVERSE CUTTING, 45CM. THE ISSUE: THE THREAD KEEPS DETACHING FROM THE NEEDLE EVERY TIME WE USE IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909511 ↗
• MalfunctionApr 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WE HAVE BEEN ADVISED BY OUR SUPPLIER (B)(4) TO CONTACT JOHNSON AND JOHNSON DIRECTLY REGARDING A FAULTY BOX OF SUTURES PURCHASE. THE SUTURES ARE ETHICON VICRYL 5/0 PS-3/8 16MM REVERSE CUTTING, 45CM. THE ISSUE: THE THREAD KEEPS DETACHING FROM THE NEEDLE EVERY TIME WE USE IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909510 ↗
• MalfunctionApr 24, 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 THE SUTURE MATERIAL DETACHING OFF NEEDLE ON BOTH LOT NO LISTED. SURGEON HAS USED THIS SUTURE FOR 10 YEARS AND NEVER HAD THIS PROBLEM UNTIL A FEW MONTHS AGO. HE THINKS ITS A QUALITY ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900079 ↗
• MalfunctionApr 24, 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 THE SUTURE MATERIAL DETACHING OFF NEEDLE ON BOTH LOT NO LISTED. SURGEON HAS USED THIS SUTURE FOR 10 YEARS AND NEVER HAD THIS PROBLEM UNTIL A FEW MONTHS AGO. HE THINKS ITS A QUALITY ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900050 ↗
• MalfunctionApr 24, 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 THE SUTURE MATERIAL DETACHING OFF NEEDLE ON BOTH LOT NO LISTED. SURGEON HAS USED THIS SUTURE FOR 10 YEARS AND NEVER HAD THIS PROBLEM UNTIL A FEW MONTHS AGO. HE THINKS ITS A QUALITY ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900037 ↗
• MalfunctionApr 24, 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 THE SUTURE MATERIAL DETACHING OFF NEEDLE ON BOTH LOT NO LISTED. SURGEON HAS USED THIS SUTURE FOR 10 YEARS AND NEVER HAD THIS PROBLEM UNTIL A FEW MONTHS AGO. HE THINKS ITS A QUALITY ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900027 ↗
• InjuryMay 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BUNIONECTOMY: CPT ¿ CAPSULE MTTARPHLNGL JT W/WO TENORRHAPHY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE PATIENT EXPERIENCED A POST OP REACTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Local Reaction; Scar Tissue; Wound Dehiscence

  MAUDE report 19398716 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032420, K132580, K181652. One submission often covers many models, so check the product and lot details in each record.

• Z-2145-2024 · May 10, 2024 · Open, Classified
  VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological
• Z-1310-2009 · Feb 2, 2009 · Terminated
  Coated VICRYL Plus Antibacterial (polyglactin 910) Suture; Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and