MONOCRYL MCP315HRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031046351), received between Apr 6, 2021 and Apr 15, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 SUTURE WAS USED. THE NURSE ADVISED THAT THE TIP BROKE OFF THE NEEDLE DURING SUTURING OF THE URETER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24888650 ↗
• 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 24619305 ↗
• 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 24619304 ↗
• 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 24619298 ↗
• 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 24619296 ↗
• MalfunctionFeb 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE DISASSEMBLED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21315157 ↗
• MalfunctionOct 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE IS BROKEN WHILE USING. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20505755 ↗
• MalfunctionApr 6, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC ABDOMINAL PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE THREE TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11623046 ↗
• MalfunctionApr 6, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC ABDOMINAL PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE THREE TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11623044 ↗
• MalfunctionApr 6, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC ABDOMINAL PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE THREE TIMES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11623035 ↗
• MalfunctionApr 6, 2021Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11622946 ↗

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