MONOCRYL Y943HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031059948), received between Jun 16, 2022 and Apr 26, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionApr 26, 2024Device Markings/Labelling Problem; Appropriate Device Problem Term/Code Not Available; Device Markings/Labelling Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED FROM THE VISUAL ANALYSIS OF A PHOTO THAT THE PACKAGE WAS CONFIRMED AS A TAMPERING PRODUCT AND DIVERSION DUE TO SEVERAL VISIBLE ERRORS. BEFORE USE ON THE PATIENT, ON (B)(6) 2024. IT WAS REPORTED THAT THAT GLOBAL BRAND PROTECTION LATAM TEAM HAS PERFORMED A MARKET SURVEY IN VENEZUELA, IN VALENCIA, 8 DIFFERENT NON-AUTHORIZED AND SUSPICIOUS SELLERS. ALL PRODUCTS BOUGHT ARE LISTED BELOW. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19195803 ↗
• MalfunctionMar 21, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SURGERY THE SUTURES WERE BREAKING EASILY AND FELT SLIPPERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587682 ↗
• MalfunctionMar 21, 2023Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SURGERY THE SUTURES WERE BREAKING EASILY AND FELT SLIPPERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587677 ↗
• MalfunctionJul 6, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14940493 ↗
• MalfunctionJun 16, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPAYING & NEUTERING OF ANIMALS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14720617 ↗

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.