MONOCRYL MCP317HRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10705031046375), received between Aug 7, 2019 and Mar 17, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Material Separation” (25 reports).

2 other recalls cover devices cleared under the same FDA submission (K050845, K201996); 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE DISTRIBUTOR THAT NEEDLES ARE DEFECTED. LAST 3 TIME THE NEEDLE COMES APART FROM THE SUTURE. NO ADVERSE IMPACT WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619577 ↗
• MalfunctionMar 17, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE DISTRIBUTOR THAT NEEDLES ARE DEFECTED. LAST 3 TIME THE NEEDLE COMES APART FROM THE SUTURE. NO ADVERSE IMPACT WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619176 ↗
• MalfunctionMar 17, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE DISTRIBUTOR THAT NEEDLES ARE DEFECTED. LAST 3 TIME THE NEEDLE COMES APART FROM THE SUTURE. NO ADVERSE IMPACT WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619172 ↗
• MalfunctionMar 17, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE DISTRIBUTOR THAT NEEDLES ARE DEFECTED. LAST 3 TIME THE NEEDLE COMES APART FROM THE SUTURE. NO ADVERSE IMPACT WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619166 ↗
• MalfunctionMar 17, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE DISTRIBUTOR THAT NEEDLES ARE DEFECTED. LAST 3 TIME THE NEEDLE COMES APART FROM THE SUTURE. NO ADVERSE IMPACT WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619163 ↗
• MalfunctionMar 17, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE DISTRIBUTOR THAT NEEDLES ARE DEFECTED. LAST 3 TIME THE NEEDLE COMES APART FROM THE SUTURE. NO ADVERSE IMPACT WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619162 ↗
• MalfunctionMar 17, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE DISTRIBUTOR THAT NEEDLES ARE DEFECTED. LAST 3 TIME THE NEEDLE COMES APART FROM THE SUTURE. NO ADVERSE IMPACT WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619161 ↗
• MalfunctionMar 17, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE DISTRIBUTOR THAT NEEDLES ARE DEFECTED. LAST 3 TIME THE NEEDLE COMES APART FROM THE SUTURE. NO ADVERSE IMPACT WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619156 ↗
• MalfunctionNov 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED PER DISTRIBUTOR THAT NEEDLE IS FALLING OFF. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618524 ↗
• MalfunctionNov 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED PER DISTRIBUTOR THAT NEEDLE IS FALLING OFF. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618523 ↗
• MalfunctionNov 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED PER DISTRIBUTOR THAT NEEDLE IS FALLING OFF. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618522 ↗
• MalfunctionNov 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED PER DISTRIBUTOR THAT NEEDLE IS FALLING OFF. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618519 ↗
• MalfunctionMar 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED A BROKEN OF SUTURE CONNECTED WITH NEEDLE WAS NOTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16551210 ↗
• MalfunctionMar 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED A BROKEN OF SUTURE CONNECTED WITH NEEDLE WAS NOTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16551207 ↗
• MalfunctionJun 7, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE FIRST STITCH, THERE WAS A NEEDLE AND THREAD SEPARATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626913 ↗
• MalfunctionFeb 1, 2022Material Separation; Difficult to Open or Remove Packaging Material; Material Separation; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BECAME DETACHED FROM THE NEEDLE AS WELL AS EXPERIENCED DIFFICULTY REMOVING THE SUTURE FROM THE DISPENSER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13420103 ↗
• MalfunctionFeb 1, 2022Material Separation; Difficult to Open or Remove Packaging Material; Material Separation; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BECAME DETACHED FROM THE NEEDLE AS WELL AS EXPERIENCED DIFFICULTY REMOVING THE SUTURE FROM THE DISPENSER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13420099 ↗
• MalfunctionFeb 1, 2022Material Separation; Difficult to Open or Remove Packaging Material; Material Separation; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BECAME DETACHED FROM THE NEEDLE AS WELL AS EXPERIENCED DIFFICULTY REMOVING THE SUTURE FROM THE DISPENSER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13420097 ↗
• MalfunctionFeb 1, 2022Material Separation; Difficult to Open or Remove Packaging Material; Material Separation; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BECAME DETACHED FROM THE NEEDLE AS WELL AS EXPERIENCED DIFFICULTY REMOVING THE SUTURE FROM THE DISPENSER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13420096 ↗
• MalfunctionMay 4, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE GOT DETACHED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11772464 ↗
• MalfunctionMay 4, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11768582 ↗
• MalfunctionMay 4, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11768579 ↗
• MalfunctionMay 3, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE GOT DETACHED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11766274 ↗
• MalfunctionMay 3, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE GOT DETACHED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11766080 ↗
• MalfunctionApr 21, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT SUTURE WAS USED DURING AN ANIMAL SURGERY ON (B)(6) 2021. THE NEEDLE DETACHED FROM THE SUTURE. THERE WERE NO CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11702165 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050845, K201996. One submission often covers many models, so check the product and lot details in each record.

• Z-2149-2024 · May 10, 2024 · Open, Classified
  MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CO
• Z-1312-2009 · Feb 2, 2009 · Terminated
  MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture; Ethicon, Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and/o