MONOCRYL Y604HRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031059474), received between Jul 27, 2020 and Nov 20, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC OOPHORECTOMY FOR OVARIAN LESIONS ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE SURGERY, WHEN THE SURGEON USED SUTURE TO SUTURE THE SKIN, THE SUTURE WAS BROKEN. AFTER REPLACING THE SUTURE WITH A NEW ONE, THE SUTURING OPERATION CONTINUED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605901 ↗
• MalfunctionSep 3, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATE CANCER SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED WHEN THE DOCTOR USED SUTURE TO SUTURE AND ANASTOMOSE THE URETHRA DURING SURGERY, THE SUTURE BROKE WHEN TIGHTENED, RESULTING IN A PROLONGED ANASTOMOSIS TIME AND POSING A SAFETY HAZARD TO THE ANASTOMOSIS EFFECT. REPLACE THE SUTURE WITH A NEW ONE AND CONTINUE WITH SURGICAL SUTURING, PROCEEDING NORMALLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20129342 ↗
• MalfunctionOct 26, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) /2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE DOCTOR WAS USING SUTURE FOR THE PATIENT, THE DOCTOR FOUND THAT THE NEEDLE AND SUTURE WERE BROKEN. THE DOCTOR IMMEDIATELY TOOK THEM OFF THE TABLE AND KEPT THEM, AND REMOVED A NEW ONE, DELAYING THE PROCESS BY ABOUT 5 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18016613 ↗
• MalfunctionJun 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, AT 12:10, WHEN THE SURGERY WAS COMPLETED AND THE SKIN WAS READY TO BE SUTURED, SUTURE WERE PUT ON THE STAGE, THE NURSE FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17173020 ↗
• MalfunctionJan 25, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENDOSCOPIC PROCEDURE ON (B)(6) 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 UROLOGICAL ENDOSCOPIC SURGERY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. UPON THE EVALUATION OF THE RETURNED SAMPLE, 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 13343651 ↗
• MalfunctionDec 21, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC APPENDECTOMY ON (B)(6) 2020 AND SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING THE INCISION AT THE TIME OF KNOTTING IN THE SURGERY. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11051796 ↗
• MalfunctionJul 27, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC RADICAL PROSTATECTOMY PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE KNOTTING. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THE SURGERY WAS DELAYED NEARLY ONE HOUR. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10326226 ↗
• MalfunctionJul 27, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC RADICAL PROSTATECTOMY PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE KNOTTING. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THE SURGERY WAS DELAYED NEARLY ONE HOUR. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10326223 ↗

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.