MONOCRYL Y353HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031058989), received between Jun 4, 2025 and May 6, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Material 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 EASILY WHEN THE DOCTOR TRIED TO HOLD THE NEEDLE WITH THE NEEDLE-HOLDER. THIS EVENT WAS FOUND BEFORE USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095484 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. CUSTOMER REPORTED EXPERIENCING BREAKAGE ISSUES WITH THE SUTURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273034 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. CUSTOMER REPORTED EXPERIENCING BREAKAGE ISSUES WITH THE SUTURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272915 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN C-SECTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT TWO SUTURES WERE PREPARED WHEN SUTURING THE MYOMETRIUM. ONE SUTURE WAS BROKEN DURING USE BUT IT WAS USED BECAUSE THE SUTURE WAS LONG ENOUGH, BUT IT WAS BROKEN AGAIN. ANOTHER SUTURE WAS USED BUT THE SAME SITUATION OCCURRED. THE THIRD AND FOURTH SUTURES WERE USED TO COMPLETE THE CASE WITHOUT PROBLEMS. IT WAS NOT A CONTROL RELEASE NEEDLE. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140879 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN C-SECTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT TWO SUTURES WERE PREPARED WHEN SUTURING THE MYOMETRIUM. ONE SUTURE WAS BROKEN DURING USE BUT IT WAS USED BECAUSE THE SUTURE WAS LONG ENOUGH, BUT IT WAS BROKEN AGAIN. ANOTHER SUTURE WAS USED BUT THE SAME SITUATION OCCURRED. THE THIRD AND FOURTH SUTURES WERE USED TO COMPLETE THE CASE WITHOUT PROBLEMS. IT WAS NOT A CONTROL RELEASE NEEDLE. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140878 ↗

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.