MONOCRYL Y605HRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705031059481), received between Aug 15, 2019 and Jan 30, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 reports).

2 other recalls cover devices cleared under the same FDA submission (K960653); 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. WHEN THE NEEDLE WAS PLACED IN THE TROLUCA, IT WAS FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE NEEDLE WAS FOUND IMMEDIATELY AND ITS INTEGRITY WAS CONFIRMED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220744 ↗
• MalfunctionDec 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. TOTAL THREE PRODUCTS HAD THE NEEDLE PULL OFF ISSUE OCCUR. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708021 ↗
• MalfunctionDec 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. TOTAL THREE PRODUCTS HAD THE NEEDLE PULL OFF ISSUE OCCUR. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707872 ↗
• MalfunctionDec 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. TOTAL THREE PRODUCTS HAD THE NEEDLE PULL OFF ISSUE OCCUR. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707760 ↗
• MalfunctionJan 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS USED TO SUTURE THE URETHRA TISSUE. DURING THE NORMAL SUTURING PROCESS, THE SUTURE SUDDENLY BROKE FROM THE MIDDLE, CHANGED TO ANOTHER ONE TO CONTINUE SUTURING, WHICH PROLONGED THE OPERATION TIME. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21178922 ↗
• MalfunctionJan 17, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21177723 ↗
• MalfunctionJan 17, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY.. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21177722 ↗
• MalfunctionOct 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED BEFORE USING ON PATIENT DURING SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20450255 ↗
• MalfunctionJul 22, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE IS SHORTER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19794603 ↗
• MalfunctionJun 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT A LAPAROSCOPIC PARTIAL COLECTOMY UNDER GENERAL ANESTHESIA FOR SIGMOID COLON CANCER ON (B)(6) 2024, AND SUTURE WAS USED ON THE INCISION. DURING THE SUTURE PROCESS, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19512840 ↗
• MalfunctionAug 19, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON 06/07/2021 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR INFERIOR MYOMECTOMY SURGERY. UPON EVALUATION OF THE DEVICE, SHORT INSERTION WAS OBSERVED IN THE STRAND. THE VISUAL INSPECTION CONCLUDED THAT THE COMBINATION OF THE NEEDLE/SUTURE WAS FOUND DETACHED SINCE THE INSERTION END OF THE SUTURE DID NOT MEET THE REQUIREMENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12342626 ↗
• MalfunctionOct 8, 2019Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE PULLED OFF THE NEEDLE WHILE IN THE NEEDLE HOLDER DEVICE CLAMPED TO DRAW THE SUTURE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORTED PATIENT CONSEQUENCE.. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9168062 ↗
• MalfunctionAug 15, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE PRIMARY PACKAGE OF THE SUTURE WAS FOUND DAMAGED PRIOR TO PLANNED USE. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE DEVICE WAS NOT USED ON THE PATIENT. UPON REVIEW OF PHOTO OF THE UNOPENED SAMPLE, IT WAS OBSERVED THAT TOP FOIL WAS RIPPED AND DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8897667 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K960653. One submission often covers many models, so check the product and lot details in each record.

• 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
• Z-1311-2009 · Feb 2, 2009 · Terminated
  MONOCRYL (poliglecaprone 25 ) Suture, Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and/or ligation.