Coated VICRYL J602HRecalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 10705031041615), received between Jan 10, 2018 and Feb 18, 2026 — classified as 2 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Material Separation” (36 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 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS FRAYED DURING USE. 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 24382871 ↗
• MalfunctionFeb 18, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS FRAYED DURING USE. 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 24382855 ↗
• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A COLECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING LAPAROSCOPIC COLECTOMY, WHEN THE DOCTOR PASSED THROUGH THE NEEDLE INTO SKIN AND ATTEMPTED TO LIFT IT, THE SWAGE PART OF THE NEEDLE BROKE. THE SAME AMOUNT OF FORCE AS USUAL WAS APPLIED, BUT THE NEEDLE BROKE. HOWEVER, THE NEEDLE HAD BEEN HELD BY A NURSE. THE PRODUCT WAS USED ON THE SKIN. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. 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 24236954 ↗
• MalfunctionDec 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SURGERY, THERE HAD BEEN A MIDDLE PART OF NEEDLE BROKEN AND A NEEDLE FELL. NO PIECES WERE LEFT INSIDE THE PATIENT, BUT THE DETAILS ARE UNKNOWN AT THIS TIME, SO IT IS BEING CONFIRMED. 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 23708283 ↗
• MalfunctionAug 25, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS FOUND THAT THERE WAS A PIECE OF CARDBOARD MIXED IN WITH THE TRANSPARENT PACKAGE, AND THE CUSTOMER WOULD LIKE TO REFRAIN FROM SHIPPING IT. THIS EVENT WAS FOUND BEFORE USE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22888804 ↗
• MalfunctionJul 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. NEEDLE BREAKAGE OCCURRED DURING THE OPERATION. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637629 ↗
• MalfunctionMay 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A LAPAROSCOPIC SURGERY, THE NEEDLE AT THE SWAGE PART WAS BROKEN DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THE TIP PART ALSO HAS BEEN RETRIEVED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010920 ↗
• MalfunctionJan 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING A LAPAROSCOPIC LEFT OVARIAN TUMOR RESECTION, DURING WOUND CLOSURE, THE NEEDLE WAS BROKEN AT THE MIDDLE PART WHEN IT PASSED THROUGH THE TISSUE AND SUTURE THE FASCIA AT THE PORT (12MM) AS USUAL. THE DOCTOR THOUGHT THE TIP OF NEEDLE AT THE MIDDLE, NOT THE SWAGE PART (THE ONE WITH THE NEEDLE) WENT TO THE PATIENT¿S BODY BUT THE NEEDLE WAS FOUND FROM DEEP INSIDE THE FASCIA. THE PRODUCT WAS USED ON THE FASCIA. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. 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 21184008 ↗
• MalfunctionSep 20, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, IT WAS NOT A CONTROL RELEASE NEEDLE. THE NEEDLE TIP WAS BROKEN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268482 ↗
• MalfunctionSep 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN APPENDECTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. ON (B)(6) 2024, AT APPROXIMATELY 12:24 PM, THE PHARMACY SATELLITE TEAM AT OT REPORTED AN INCIDENT WHERE THE SUTURE DETACHED FROM THE NEEDLE BODY WHEN ATTEMPTING TO USE THE SUTURE DURING A VLA OPERATION BY THE OPERATOR. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181113 ↗
• MalfunctionJul 3, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19664713 ↗
• MalfunctionJun 13, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC APPENDECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, FOREIGN MATTER LIKE COTTON FOUND ON THE NEEDLE TIP. THE NEW PRODUCT WAS USED. THE PRODUCT WAS USED AT THE PLACE TO STAND THE PORT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19532380 ↗
• MalfunctionFeb 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING AN UNKNOWN RESPIRATORY SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE. THE SURGEON STOPPED USING THE PRODUCT. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18759912 ↗
• MalfunctionFeb 2, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON WAS ABOUT TO USE THE PRODUCT, THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636591 ↗
• MalfunctionOct 25, 2023Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004759 ↗
• MalfunctionOct 25, 2023Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004245 ↗
• MalfunctionSep 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE WHEN THE SURGEON APPLIED THE FIRST STITCH ON TISSUE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17774541 ↗
• MalfunctionJul 24, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING USE MANY TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17382071 ↗
• MalfunctionJul 24, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 04/07/2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING USE MANY TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17382069 ↗
• MalfunctionJul 24, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING USE MANY TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17382063 ↗
• MalfunctionJul 24, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING USE MANY TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17382058 ↗
• MalfunctionJul 24, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING USE MANY TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17382048 ↗
• MalfunctionJun 22, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, AFTER OPENING THE PACKAGE AND BEFORE USE, IT WAS FOUND THAT THE SUTURE WAS PARTIALLY THICKENED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17181520 ↗
• MalfunctionJun 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE OB-GYN SURGERY, WHEN THE SURGEON APPLIED THE PRODUCT ON FASCIAL TISSUE, THE NEEDLE WAS DETACHED FROM THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17126071 ↗
• MalfunctionMay 10, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, BEFORE USE THE SURGEON HELD THE PRODUCT WITH FORCEPS, HE REALIZED THAT THE SUTURE WAS UNTIED. ON(B)(4) 2023 ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE SUTURE WAS FRAYED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16908596 ↗

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