MONOCRYL Y213HRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031058569), received between Apr 12, 2022 and Apr 14, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISION OF AN UMBILICAL AND RIGHT FOOT KELOID PROCEDURE ON AN UNKNOWN DATE SUTURE WAS USED. THE NEEDLE BROKE IN HALF WHILE THE SURGEON WAS CLOSING AN EXCISION OF AN UMBILICAL AND RIGHT FOOT KELOID. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877139 ↗
• MalfunctionApr 1, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FOOT PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE IN HALF WHILE THE SURGEON WAS CLOSING AN EXCISION OF AN UMBILICAL AND RIGHT FOOT KELOID. NO DELAY OR PATIENT HARM WAS REPORTED. DEVICE AVAILABILITY WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24753747 ↗
• MalfunctionAug 14, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025, AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED BEFORE USING ON PATIENT DURING SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809405 ↗
• MalfunctionJun 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE BREAKS OF THREAD TO EASILY DURING SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308529 ↗
• MalfunctionNov 30, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE OFF, IT NOT KNOWN WHEN THE EVENT OCCURRED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15885710 ↗
• MalfunctionApr 12, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GENERAL SURGERY ON UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TWO OR THREE NEEDLES POPPED OFF OF THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14084738 ↗
• MalfunctionApr 12, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GENERAL SURGERY ON UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TWO OR THREE NEEDLES POPPED OFF OF THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14084736 ↗
• MalfunctionApr 12, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GENERAL SURGERY ON UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TWO OR THREE NEEDLES POPPED OFF OF THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14084729 ↗

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