Coated VICRYL VCP304H (UDI 10705031052116)Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 10705031052116), received between Oct 3, 2018 and Sep 29, 2026 — classified as 7 injuries, 89 malfunctions.

The most frequently reported specific device problem is “Material Separation” (52 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 96 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931023 ↗
• MalfunctionAug 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50299062 ↗
• MalfunctionAug 6, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. In the surgical procedure without specifying the doctor requests the suture to be able to perform the closure, however at the time that the nurse gives the needles and the doctor takes it, it breaks, so he requests another one to be able to continue. the second one is given, and it breaks again when the third suture is passed, it breaks again validating that it is the same batch, so they make the product report. There was a 15 minute surgical delay reported. There was no patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50157494 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DERMATOLOGIC PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE PATIENT RETURNED TO THE CLINIC WITH A SURGICAL SITE INFECTION. SINCE THIS RATE IS MUCH HIGHER THAT THE NORMAL PERCENTAGE OF PATIENTS WITH AN SSI THE HCP QUESTIONS IF THERE WAS A DIFFERENCE IN THE BATCH OF SUTURES USED. BESIDES, SHE MENTIONED THAT THE PATIENTS WITH SSI WERE ELDERLY WITH LARGE WOUNDS, WHICH MIGHT ALSO EXPLAIN THE HIGHTENED SSI PERCENTAGE. LOT NUMBER THOUGHT TO BE XCBBWHC0 (HOWEVER NOT CERTAIN). ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 25581352 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DERMATOLOGIC PROCEDURE ON (B)(6) OR (B)(6) 2026 AND SUTURE WAS USED. THE PATIENT RETURNED TO THE CLINIC WITH A SURGICAL SITE INFECTION. SINCE THIS RATE IS MUCH HIGHER THAT THE NORMAL PERCENTAGE OF PATIENTS WITH AN SSI THE HCP QUESTIONS IF THERE WAS A DIFFERENCE IN THE BATCH OF SUTURES USED. BESIDES, SHE MENTIONED THAT THE PATIENTS WITH SSI WERE ELDERLY WITH LARGE WOUNDS, WHICH MIGHT ALSO EXPLAIN THE HIGHTENED SSI PERCENTAGE. LOT NUMBER THOUGHT TO BE XCBBWHC0 (HOWEVER NOT CERTAIN). ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 25581283 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DERMATOLOGIC PROCEDURE ON (B)(6) OR (B)(6) 2026 AND SUTURE WAS USED. THE PATIENT RETURNED TO THE CLINIC WITH A SURGICAL SITE INFECTION. SINCE THIS RATE IS MUCH HIGHER THAT THE NORMAL PERCENTAGE OF PATIENTS WITH AN SSI THE HCP QUESTIONS IF THERE WAS A DIFFERENCE IN THE BATCH OF SUTURES USED. BESIDES, SHE MENTIONED THAT THE PATIENTS WITH SSI WERE ELDERLY WITH LARGE WOUNDS, WHICH MIGHT ALSO EXPLAIN THE HIGHTENED SSI PERCENTAGE. LOT NUMBER THOUGHT TO BE XCBBWHC0 (HOWEVER NOT CERTAIN). ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 25581273 ↗
• MalfunctionMay 4, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 20/04/2026 AND SUTURE WAS USED. BEFORE USE, CUSTOMERS HAVE REPORTED THAT THE QRQODE ON OUR PRODUCT PACKAGING IS BLURRY AND CANNOT BE SCANNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25069511 ↗
• MalfunctionApr 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE SUTURING OF THE PATIENT¿S SOFT TISSUES, THE NEEDLE DETACHED FROM THE THREAD. A NEW BLISTER WAS OPENED. THE WOUND WAS CLOSED USING ANOTHER SUTURE MATERIAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971438 ↗
• MalfunctionApr 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE SUTURING OF THE PATIENT¿S SOFT TISSUES, THE NEEDLE DETACHED FROM THE THREAD. A NEW BLISTER WAS OPENED. THE WOUND WAS CLOSED USING ANOTHER SUTURE MATERIAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971368 ↗
• MalfunctionApr 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) /2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BREAKS AS SOON AS IT IS PULLED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24889455 ↗
• MalfunctionApr 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24862581 ↗
• MalfunctionApr 7, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SURGERY, THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800468 ↗
• MalfunctionFeb 24, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE SUTURING OF THE PATIENT¿S SOFT TISSUES, THE NEEDLE DETACHED FROM THE THREAD. A NEW BLISTER WAS OPENED. THE WOUND WAS CLOSED USING ANOTHER SUTURE MATERIAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434925 ↗
• MalfunctionFeb 24, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE SUTURING OF THE PATIENT¿S SOFT TISSUES, THE NEEDLE DETACHED FROM THE THREAD. A NEW BLISTER WAS OPENED. THE WOUND WAS CLOSED USING ANOTHER SUTURE MATERIAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434923 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23016855 ↗
• MalfunctionAug 29, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. PRIOR TO USE ON THE PATIENT, THE SUTURE PULLED OFF THE NEEDLE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. UPON EVALUATION OF THE RETURNED DEVICE, THE NEEDLE WAS FOUND BROKEN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922677 ↗
• MalfunctionAug 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE DOCTOR SUTURED THE CHILD WITH SUTURE. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN SUTURING. OTHER SUTURE WAS USED TO COMPLETE THE SUTURE FOR THE CHILD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22914356 ↗
• MalfunctionMay 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT A SUTURE PRESENTED A DEFECT DURING USE - THE NEEDLE CAME LOOSE FROM THE THREAD. 05 THREADS THAT PRESENTED THE SAME PROBLEM WERE USED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959580 ↗
• MalfunctionMay 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT A SUTURE PRESENTED A DEFECT DURING USE - THE NEEDLE CAME LOOSE FROM THE THREAD. 05 THREADS THAT PRESENTED THE SAME PROBLEM WERE USED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959576 ↗
• MalfunctionMay 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT A SUTURE PRESENTED A DEFECT DURING USE - THE NEEDLE CAME LOOSE FROM THE THREAD. 05 THREADS THAT PRESENTED THE SAME PROBLEM WERE USED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959573 ↗
• MalfunctionMay 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT A SUTURE PRESENTED A DEFECT DURING USE - THE NEEDLE CAME LOOSE FROM THE THREAD. 05 THREADS THAT PRESENTED THE SAME PROBLEM WERE USED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959539 ↗
• MalfunctionMay 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT A SUTURE PRESENTED A DEFECT DURING USE, THE NEEDLE CAME LOOSE FROM THE THREAD. 05 THREADS THAT PRESENTED THE SAME PROBLEM WERE USED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959536 ↗
• MalfunctionApr 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC URETEROLITHOTOMY SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT UNDERWENT SURGERY ON THE MORNING. DURING THE LAPAROSCOPIC URETEROLITHOTOMY SURGERY, WHEN THE SURGEON WAS SUTURING THE SKIN, THE TAIL OF THE NEEDLE SUDDENLY BROKE, AND THE SURGERY WAS IMMEDIATELY STOPPED. AFTER TWO PEOPLE CHECKED, IT WAS CONFIRMED THAT THE NEEDLE BODY WAS COMPLETE. IMMEDIATELY REPLACED THE SUTURE WITH A NEW ONE FOR SUTURING AND USED NORMALLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21936317 ↗
• MalfunctionMar 24, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT CONFIRMED COUNTERFEIT WAS OBSERVED. IT WAS REPORTED ON (B)(6)2024 THAT THE DISTRIBUTOR DENTAL GANA NOTIFIED THAT THESE CODIGS AND LOTS WERE SOLD TO A CUSTOMER IN CHILE BY A COMPANY THAT WE DO NOT HAVE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21681533 ↗
• MalfunctionMar 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE HERNIA SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664434 ↗

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