MONOCRYL Y495GRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031059351), received between Sep 6, 2019 and Nov 11, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionNov 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, WHEN OPENING THE TWINE PACKAGING, THE DOCTOR HELD THE NEEDLE WITH THE NEEDLE HOLDER AND WHEN PULLING THE TWINE OUT OF THE PLASTIC PACKAGING, THE TWINE UNCOACHED (THE WIRE CAME LOOSE). THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525931 ↗
• MalfunctionJul 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. THE THREAD WITH NEEDLE DISCONNECTED FROM THE THREAD, MAKING IT IMPOSSIBLE TO USE. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19711594 ↗
• MalfunctionMar 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FACELIFT PROCEDURE ON 02/22/2023 AND SUTURE WAS USED. AS THE SURGEON WAS TYING THE SUTURE OFF, THEY WERE POPPING OFF. HE KEPT TRYING UNTIL IT WORKED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16586604 ↗
• MalfunctionMar 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FACELIFT PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. AS THE SURGEON WAS TYING THE SUTURE OFF, THEY WERE POPPING OFF. HE KEPT TRYING UNTIL IT WORKED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16586593 ↗
• MalfunctionJun 22, 2022Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE DETACHED FROM THE THREAD DURING THE PROCEDURE. NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14779320 ↗
• MalfunctionJun 22, 2022Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE DETACHED FROM THE THREAD DURING THE PROCEDURE. NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14779267 ↗
• MalfunctionJun 22, 2022Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE DETACHED FROM THE THREAD DURING THE PROCEDURE. NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14779263 ↗
• MalfunctionSep 6, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8971136 ↗

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