MONOCRYL Y823GRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031059658), received between Apr 18, 2023 and Jun 5, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K964072); 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.

• MalfunctionJun 5, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE SUTURE WAS REPORTED TO BE DEFECTIVE. IT WAS NOT USED ON THE PATIENT, AND THERE WAS NO PATIENT HARM. THE SUTURE WAS NOTICED TO BE DOUBLE-ARMED ON THE BACK TABLE. THE CASE WAS COMPLETED USING A DIFFERENT LOT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19466910 ↗
• MalfunctionApr 18, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2023 AND SUTURE WAS USED TO SUTURE SUBCUTANEOUS LAYER OF TISSUE AT THE END OF THE PROCEDURE. DURING THE PROCEDURE, THE SUTURE STRAND WAS FRAYING. THE PROCEDURE WAS DELAYED 10 MINUTES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765564 ↗
• MalfunctionApr 18, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2023 AND SUTURE WAS USED TO SUTURE SUBCUTANEOUS LAYER OF TISSUE AT THE END OF THE PROCEDURE. DURING THE PROCEDURE, THE SUTURE STRAND WAS FRAYING. THE PROCEDURE WAS DELAYED 10 MINUTES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765514 ↗
• MalfunctionApr 18, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2023 AND SUTURE WAS USED TO SUTURE SUBCUTANEOUS LAYER OF TISSUE AT THE END OF THE PROCEDURE. DURING THE PROCEDURE, THE SUTURE STRAND WAS FRAYING. THE PROCEDURE WAS DELAYED 10 MINUTES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765512 ↗
• MalfunctionApr 18, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON(B)(6) 2023 AND SUTURE WAS USED TO SUTURE SUBCUTANEOUS LAYER OF TISSUE AT THE END OF THE PROCEDURE. DURING THE PROCEDURE, THE SUTURE STRAND WAS FRAYING. THE PROCEDURE WAS DELAYED 10 MINUTES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765511 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964072. One submission often covers many models, so check the product and lot details in each record.

• Z-0487-2025 · Oct 8, 2024 · Open, Classified
  MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and
• 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