MONOCRYL MCP490GRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031046542), received between May 1, 2019 and May 6, 2026 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN FACE PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE OF SUTURING A WOUND ON THE FACE, WHILE THE DOCTOR WAS DOING THE CLOSING OF THE SKIN, THE NEEDLE WAS DETACHED FROM THE THREAD OF THE SUTURE AS IT PASSED THE POINT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094459 ↗
• MalfunctionApr 17, 2026Material Frayed; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE PEELED WHEN THE NEEDLE PASSED, CAUSING THE THREAD TO LOOSE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913764 ↗
• MalfunctionApr 17, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE HEAD BROKE AS THE NEEDLE PASSED THROUGH, CAUSING THE THREAD TO COME LOOSE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912699 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. CASE LOGGED IN RELATION TO THE SECOND INCIDENT MENTIONED IN (B)(4). SHE COMMENTED THAT THIS HAD ALSO HAPPENED SOME MONTHS PRIOR, ALBEIT ON A 3/0 MONOCRYL. SHE INFORMED ME THAT THE NEEDLE TIP WAS NOT RECOVERED AND THAT THE PATIENT HAD BEEN SENT FOR A CT SCAN - WHICH SUGGESTED THAT THE NEEDLE TIP WAS IN-SITU. I ASKED HER TO RETAIN THE SUTURE AND NEEDLE. HOWEVER, THESE HAD ALREADY BEEN DISPOSED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714901 ↗
• MalfunctionJan 22, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE THREADS WERE BREAKING CONSISTENTLY. NO PATIENT CONSEQUENCES REPORTED WHEN THIS COMPLAINT EVENT OCCURRED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24146673 ↗
• MalfunctionMar 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN APPENDECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT IS REPORTED THAT WHEN THE PATIENT IS SUTURED, THE THREAD IS RELEASED, CAUSING THE NEEDLE TO UNTIE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691294 ↗
• InjuryOct 17, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DE QUERVAIN'S SYNDROME RELEASE PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, THE PATIENT HAD DELAYED ABSORPTION AND DID NOT ABSORB WELL. THE PATIENT EXPERIENCED IRRITATION AT THE SUTURE SITE AND FELT THAT THERE WERE SUTURE REMNANTS UNDER HER SKIN EVEN AFTER 3 MONTHS POST-OP. ON (B)(6) 2024, THE DOCTOR REVISED THE SCAR WITH A DIFFERENT SUTURE AND REMOVED ALL THE REMNANT SUTURES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Discomfort; Skin Inflammation/ Irritation

  MAUDE report 20472360 ↗
• InjuryOct 17, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DE QUERVAIN'S SYNDROME RELEASE PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, THE PATIENT HAD DELAYED ABSORPTION AND DID NOT ABSORB WELL. THE PATIENT EXPERIENCED IRRITATION AT THE SUTURE SITE. THE SKIN WAS RAISED. ABOUT 1 MONTH AFTER THE OPERATION ON (B)(6) 2024, THE DOCTOR REMOVED THE SUTURE, PROVIDED WOUND CARE ADVICE, AND PUT A DRESSING ON. THE PATIENT IS CURRENTLY DOING FINE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Discomfort; Skin Inflammation/ Irritation

  MAUDE report 20472339 ↗
• InjuryOct 17, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DE QUERVAIN'S SYNDROME RELEASE PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. POST-OP, THE PATIENT HAD DELAYED ABSORPTION AND DID NOT ABSORB WELL. THE PATIENT EXPERIENCED IRRITATION AT THE SUTURE SITE. THE SKIN WAS RAISED. AFTER POST-OP 3 WEEKS, THE PATIENT HAD IRRITATION AT SUTURE SITE. IT WAS STATED THAT THE REACTION WAS NOTED ON (B)(6) 2024. THE DOCTOR REMOVED THE SUTURE, PROVIDED WOUND CARE ADVICE, AND PUT A DRESSING ON. THE PATIENT IS CURRENTLY DOING FINE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Discomfort; Skin Inflammation/ Irritation

  MAUDE report 20472297 ↗
• MalfunctionAug 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. THE SECOND SUTURE IS PASSED TO THE TABLE, THE NEEDLE BECOMES DETACHED FROM THE THREAD WHEN PASSING THROUGH THE TISSUE FOR THE FIRST TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977602 ↗
• MalfunctionFeb 22, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE'S NEEDLE AND LINE IS SEPARATE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13579428 ↗
• MalfunctionFeb 17, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE'S NEEDLE AND LINE IS SEPARATE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13554563 ↗
• MalfunctionSep 11, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10521162 ↗
• MalfunctionMay 1, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GRAFT PROCEDURE IN THE RIGHT LEG ON AN UNKNOWN DATE IN 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE STAYED IN THE NEEDLE HOLDER, AND THE SUTURE DISASSEMBLED FROM THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8569145 ↗

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