MONOCRYL Y987HRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031060005), received between Dec 4, 2018 and Oct 15, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON REPORTED THAT IN ALL THREE CASES, THE PATIENTS EXPERIENCED BODY WALL DEHISCENCE WITHIN TWO DAYS POST-OPERATION, WITH ONE PATIENT EXPERIENCING WOUND RUPTURE AT 11 DAYS POST-OP AND ANOTHER AT 15 DAYS POST-OP. ALL THREE PATIENTS REQUIRED EMERGENCY CARE. THE DEVICES ARE AVAILABLE FOR RETURN. THE EVENT IS BEING REPORTED FOR DOCUMENTATION PURPOSES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 23289412 ↗
• MalfunctionOct 15, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON REPORTED THAT IN ALL THREE CASES, THE PATIENTS EXPERIENCED BODY WALL DEHISCENCE WITHIN TWO DAYS POST-OPERATION, WITH ONE PATIENT EXPERIENCING WOUND RUPTURE AT 11 DAYS POST-OP AND ANOTHER AT 15 DAYS POST-OP. ALL THREE PATIENTS REQUIRED EMERGENCY CARE. THE DEVICES ARE AVAILABLE FOR RETURN. THE EVENT IS BEING REPORTED FOR DOCUMENTATION PURPOSES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 23289288 ↗
• MalfunctionOct 15, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON REPORTED THAT IN ALL THREE CASES, THE PATIENTS EXPERIENCED BODY WALL DEHISCENCE WITHIN TWO DAYS POST-OPERATION, WITH ONE PATIENT EXPERIENCING WOUND RUPTURE AT 11 DAYS POST-OP AND ANOTHER AT 15 DAYS POST-OP. ALL THREE PATIENTS REQUIRED EMERGENCY CARE. THE DEVICES ARE AVAILABLE FOR RETURN. THE EVENT IS BEING REPORTED FOR DOCUMENTATION PURPOSES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 23289269 ↗
• MalfunctionJul 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ANIMAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING ANIMAL SURGERY THE NEEDLE BROKE OFF INTO THE DOG. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17365291 ↗
• MalfunctionNov 14, 2019Break; Break

  IT WAS REPORTED BY VET THAT A DOG UNDERWENT AN ANIMAL SURGERY ON (B)(6) 2019 AND THE SUTURE WAS USED TO CLOSE THE INCISION. THE SUTURE HAD NO DEFECTS THAT COULD BE OBSERVED DURING THE SURGERY. THEN POST-OPERATIVELY, THE SUTURE WAS FOUND TO BE BROKEN DOWN IN INCISION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9325658 ↗
• MalfunctionNov 14, 2019Break; Break

  IT WAS REPORTED BY VET THAT A DOG UNDERWENT AN ANIMAL SURGERY ON (B)(6) 2019 AND THE SUTURE WAS USED TO CLOSE THE INCISION. POST-OPERATIVELY, THE SUTURE WAS FOUND TO BE BROKEN DOWN IN INCISION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9325574 ↗
• MalfunctionDec 4, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND A SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE WHEN SURGEON JUST PULLED BY HAND. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8131151 ↗

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.