MONOCRYL Y426HRecalls & reported problems

Summary

The FDA's MAUDE database contains 141 adverse event reports that list this exact device (DI 10705031059146), received between Dec 12, 2017 and Sep 24, 2026 — classified as 17 injuries, 124 malfunctions.

The most frequently reported specific device problem is “Break” (105 reports).

2 other recalls cover devices cleared under the same FDA submission (K964072); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 141 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Break

  It was reported a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. Brittle hair strands, breaking during use. Additional information has been requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888512 ↗
• MalfunctionJul 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25849270 ↗
• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT IN 2 CASES THEY HAD A NEEDLE BREAK. AN X RAY WAS DONE BUT WERE NOT ABLE TO BE FOUND. THERE WAS NO ISSUES WITH THE PATIENTS. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25201902 ↗
• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED PROCEDURE, THE NEEDLE IS SHEARING AND BREAKING OFF. THERE WERE NO PATIENT CONSEQUENCES REPORTED. 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 23728528 ↗
• MalfunctionNov 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED PROCEDURE, THE NEEDLE IS SHEARING AND BREAKING OFF. THERE WERE NO PATIENT CONSEQUENCES REPORTED. 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 23489817 ↗
• MalfunctionNov 4, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THERE WAS ONE NEEDLE MORE THAN EXPECTED IN THE NEWLY DISPENSED SUTURE WHEN PREPARING FOR SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ACCORDING TO SALE REP FEEDBACK BY PHONE, THIS CODE SHOULD BE ONE NEEDLE SUTURE, BUT OPEN THE PACKAGE, THE PRODUCT IS TWO-ARM NEEDLE SUTURE, NOT ONLY EXTRA NEEDLE. PLEASE SEE ATTACHED PHOTO. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466627 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED KELOID FORMATION, SUTURE ABSCESS, AND INCREASED POST-OP SOFT TISSUE INFECTION SINCE UNDERGOING THE ELECTIVE SURGERY. IT WAS OPINED BY THE SURGEON THAT, SINCE CHANGING SUTURES, THE EVENT WAS DUE TO THE SUTURE'S LONGER REABSORPTION TIME. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Impaired Healing; Unspecified Infection

  MAUDE report 22772671 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED KELOID FORMATION, SUTURE ABSCESS, AND INCREASED POST-OP SOFT TISSUE INFECTION SINCE UNDERGOING THE ELECTIVE SURGERY. IT WAS OPINED BY THE SURGEON THAT, SINCE CHANGING SUTURES, THE EVENT WAS DUE TO THE SUTURE'S LONGER REABSORPTION TIME. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Impaired Healing; Unspecified Infection

  MAUDE report 22772668 ↗
• MalfunctionAug 1, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SKIN CLOSURE PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SKIN CLOSURE THE DEVICE IS BENDING AND BREAKING. NO PATIENT CONSEQUENCES WAS REPORTED. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22688031 ↗
• MalfunctionAug 1, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE HAS BEEN BREAKING OR BENDING WHEN BEING USED TO CONDUCT SKIN CLOSURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686321 ↗
• MalfunctionAug 1, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE HAS BEEN BREAKING OR BENDING WHEN BEING USED TO CONDUCT SKIN CLOSURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686304 ↗
• MalfunctionAug 1, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE HAS BEEN BREAKING OR BENDING WHEN BEING USED TO CONDUCT SKIN CLOSURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686284 ↗
• MalfunctionAug 1, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE HAS BEEN BREAKING OR BENDING WHEN BEING USED TO CONDUCT SKIN CLOSURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686283 ↗
• MalfunctionAug 1, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE HAS BEEN BREAKING OR BENDING WHEN BEING USED TO CONDUCT SKIN CLOSURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686274 ↗
• MalfunctionAug 1, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE HAS BEEN BREAKING OR BENDING WHEN BEING USED TO CONDUCT SKIN CLOSURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686269 ↗
• MalfunctionAug 1, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE HAS BEEN BREAKING OR BENDING WHEN BEING USED TO CONDUCT SKIN CLOSURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686250 ↗
• MalfunctionAug 1, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE HAS BEEN BREAKING OR BENDING WHEN BEING USED TO CONDUCT SKIN CLOSURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686241 ↗
• MalfunctionAug 1, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE HAS BEEN BREAKING OR BENDING WHEN BEING USED TO CONDUCT SKIN CLOSURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686237 ↗
• MalfunctionAug 1, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE HAS BEEN BREAKING OR BENDING WHEN BEING USED TO CONDUCT SKIN CLOSURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686144 ↗
• MalfunctionJul 9, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT BREAKING WHEN TYING THE SUTURE DOWN. NO ADVERSE IMPACT PATIENT/USER. THE DEVICE IS NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460388 ↗
• MalfunctionMay 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC UROLOGY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE OFF INTO THE PATIENT. AN X-RAY WAS DONE AND THE PATIENT WAS CLOSED WITH THE TIP OF THE NEEDLE LEFT. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22012801 ↗
• MalfunctionMar 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GENERAL SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING A GENERAL PROCEDURE, WHILE CLOSING TROCAR PORTS. THE SUTURE BROKE IN RANDOM SPOTS. ANOTHER LIKE DEVICE WOULD BE USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO SAMPLES RETURNING. NO ADDITIONAL INFORMATION REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21679307 ↗
• MalfunctionMar 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE REP THAT OVER THE PAST MONTH DURING MULTIPLE PROCEDURES THAT THE SUTURE IS BREAKING IN RANDOM SPOTS. ANOTHER LIKE DEVICE WOULD BE USED TO CONTINUE WITH THE PROCEDURE. NO SAMPLES RETURNING. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678854 ↗
• MalfunctionMar 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE REP THAT OVER THE PAST MONTH DURING MULTIPLE PROCEDURES THAT THE SUTURE IS BREAKING IN RANDOM SPOTS. ANOTHER LIKE DEVICE WOULD BE USED TO CONTINUE WITH THE PROCEDURE. NO SAMPLES RETURNING. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678292 ↗
• MalfunctionSep 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE THREADS ARE FRAGILE WHEN HANDLED, BREAKING DURING USE, BOTH USED IN THE SAME SURGERY. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20140145 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964072. One submission often covers many models, so check the product and lot details in each record.

• Z-0487-2025 · Oct 8, 2024 · Open, Classified
  MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and
• Z-2148-2024 · May 10, 2024 · Open, Classified
  MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345