MONOCRYL MCP358HRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031046450), received between Jul 18, 2023 and Mar 24, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE PULL OFF DURING THE PROCEDURE. THERE WERE NO SIGNIFICANT DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681244 ↗
• MalfunctionJan 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A SURGERY, THE SUTURE REPEATEDLY BROKE. THERE WERE NO SURGICAL DELAYS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24119164 ↗
• MalfunctionJan 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A SURGERY, THE SUTURE REPEATEDLY BROKE. THERE WERE NO SURGICAL DELAYS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24119156 ↗
• MalfunctionFeb 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307740 ↗
• MalfunctionFeb 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307739 ↗
• MalfunctionFeb 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN C-SECTION PROCEDURE ON (B)(6)2025 AND A SUTURE WAS USED. DURING SURGERY IT WAS RECOGNIZED THAT THE TIP OF AN ATRAUMATIC WAS MISSING. THE NEEDLE REMAINED ON THE SUTURE; THE TIP WAS MISSING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307006 ↗
• MalfunctionJan 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REPEAT C-SECTION PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. THE SURGICAL STAFF OBSERVED THE NEEDLE TIP ON THE SUTURE HAD BROKEN OFF. IT IS UNKNOWN IF IT CAME LIKE THAT OUT OF THE PACKAGE OR IF IT BROKE OFF DURING ARMING/USE. PATIENT WAS X-RAYED AND DID NOT FIND NEEDLE STILL INSIDE. NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE. NO SURGICAL DELAY WAS REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21183998 ↗
• MalfunctionJul 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE THE NEEDLE CAME OFF THE SWAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17341094 ↗

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