MONOCRYL MCP316HRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10705031046368), received between Jan 23, 2018 and Apr 21, 2026 — classified as 1 injury, 25 malfunctions.

The most frequently reported specific device problem is “Break” (16 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.

• MalfunctionApr 21, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE INCIDENT OCCURRED DURING A LAPAROSCOPIC CHOLECYSTECTOMY, AT WHICH POINT THE NEEDLE DETACHED FROM THE THREAD. WHILE THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT, THE EVENT POSED A POTENTIAL RISK OF NEEDLE LOSS IN THE SURGICAL FIELD. IT IS WORTH MENTIONING THAT IT IS THE FIRST CASE OF THIS TYPE THAT WE HAVE REGISTERED WITH THIS INPUT. THE EVENT HAS ALREADY BEEN ENTERED INTO OUR TECHNOVIGILANCE SYSTEM AND ATTACHED THE PHOTOGRAPHS OF THE PRODUCT FOR ANALYSIS AND MONITORING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO SURGICAL DELAYS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24939933 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE TIP BROKE OFF WHILE THE DOCTOR CLOSING THE PATIENTS SKIN LAYER THE TECH NOTICE IT THE TIP ON THE NEEDLE DRIVER AND THE ENTIRE NEEDLE TIP. THERE WAS NO NEGATIVE OUTCOME. PRODUCT AS DISCARDED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958737 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN CANINE SPAY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BREAKS WITHOUT PUTTING MUCH TENSILE PRESSURE ON IT - LEADING TO INCISION DEHISCENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 23958655 ↗
• MalfunctionSep 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, DOCTOR USED SUTURE FOR SUTURING. DURING USE, IT WAS FOUND THAT THE SUTURE AND NEEDLE WERE BROKEN. THE DOCTOR REPLACED THE SUTURE FOR SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23184473 ↗
• MalfunctionJul 31, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT DURING AN UNKNOWN PROCEDURE, THE 2 SUTURE IN THE SAME BOX IS TRIVIAL AND EASILY BROKE. THE DEVICE IS NOT AVAILABLE FOR RETURN. THEY JUST WANTED TO REPORT THE FAULTY PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677111 ↗
• MalfunctionJul 31, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT DURING AN UNKNOWN PROCEDURE, THE 2 SUTURE IN THE SAME BOX IS TRIVIAL AND EASILY BROKE. THE DEVICE IS NOT AVAILABLE FOR RETURN. THEY JUST WANTED TO REPORT THE FAULTY PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677109 ↗
• MalfunctionJul 31, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT DURING AN UNKNOWN PROCEDURE, THE 2 SUTURE IN THE SAME BOX IS TRIVIAL AND EASILY BROKE. THE DEVICE IS NOT AVAILABLE FOR RETURN. THEY JUST WANTED TO REPORT THE FAULTY PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677101 ↗
• MalfunctionJul 31, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT DURING AN UNKNOWN PROCEDURE, THE 2 SUTURE IN THE SAME BOX IS TRIVIAL AND EASILY BROKE. THE DEVICE IS NOT AVAILABLE FOR RETURN. THEY JUST WANTED TO REPORT THE FAULTY PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677100 ↗
• MalfunctionJun 11, 2024Delivered as Unsterile Product; Defective Component; Delivered as Unsterile Product; Defective Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE NEEDLE WAS RUSTY AT THE PACKAGE OPENING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509998 ↗
• MalfunctionJan 29, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE STRANDS ARE CUT IN HALF OR ON THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18594434 ↗
• MalfunctionJan 29, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE STRANDS ARE CUT IN HALF OR ON THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18594428 ↗
• MalfunctionJun 16, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THERE WAS A PHENOMENON OF CONTINUOUS DISCONNECTION DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17143879 ↗
• MalfunctionMay 22, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE USER USED THE SUTURE ONE TIME AND THEN DURING THE SECOND TIME IT FRAYED ON THE SECOND USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16974176 ↗
• MalfunctionDec 29, 2022Positioning Failure; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL SOME SUTURE THAT SEEMS TO BE DEFECTIVE, AS THE KNOTS HAVE SUDDENLY STARTED COMING UNTIED, NOTHING HAS CHANGED ABOUT HOW KNOTS ARE TIED, BUT HAD TWO PATIENTS IN A ROW COME BACK A DAY AFTER SURGERY WITH THEIR INCISIONS WIDE OPEN AND HALF THEIR SUTURES UNTIED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 16074678 ↗
• MalfunctionDec 29, 2022Positioning Failure; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL SOME SUTURE THAT SEEMS TO BE DEFECTIVE, AS THE KNOTS HAVE SUDDENLY STARTED COMING UNTIED, NOTHING HAS CHANGED ABOUT HOW KNOTS ARE TIED BUT HAD TWO PATIENTS IN A ROW COME BACK A DAY AFTER SURGERY WITH THEIR INCISIONS WIDE OPEN AND HALF THEIR SUTURES UNTIED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 16074677 ↗
• MalfunctionApr 18, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. POST-OPERATIVELY THE PATIENT CAME IN AND THE INCISION WAS VERIFIED, THEY COULD SEE THAT IT WAS OPENED, AND THE STITCHES HAD DISINTEGRATED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14136296 ↗
• MalfunctionDec 10, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LOW ANTERIOR RESECTION PROCEDURE ON AN UNKNOWN DATE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE AND NEEDLE DETACHED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12975244 ↗
• MalfunctionAug 16, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GASTRIC BYPASS SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS CUT. THE DOCTOR WAS VERY CAREFUL NOT TO USE EXCESSIVE FORCE WHEN TYING THE KNOTS. ANOTHER LIKE DEVICE WAS USED. THE SURGERY WAS DELAYED BY 15 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12324755 ↗
• MalfunctionAug 12, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC BYPASS PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12314128 ↗
• MalfunctionAug 12, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC BYPASS PROCEDURE ON 07/19/2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12314125 ↗
• MalfunctionDec 17, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GASTRIC BYPASS PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE LEAVES ITS UNION WHEN PASSING THROUGH THE TROCAR. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9482089 ↗
• MalfunctionAug 15, 2019Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE IS BREAKING DURING THE TYING PROCEDURE. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8896869 ↗
• MalfunctionJul 23, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LABIAPLASTY PROCEDURE ON (B)(6) 2019 AND THE SUTURE WAS USED. DURING SUTURING, NEEDLE TIP BROKE AND IT REQUIRED LONGER GA TIME TO LOOK FOR THE NEEDLE, WHICH HAS BEEN LOCATED AND THEN DROPPED ON THE FLOOR AS IT WAS SO SMALL. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8819921 ↗
• MalfunctionJan 3, 2019Break; Tear, Rip or Hole in Device Packaging; Break; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE DID NOT HAVE A NEEDLE. THE DEVICE WAS RETURNED FOR EVALUATION. UPON EVALUATION, SUTURE DEGRADATION AND HOLES IN THE PACKAGE WERE FOUND. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8215809 ↗
• MalfunctionJun 13, 2018Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT UPON OPENING THE SUTURE BOX ON AN UNKNOWN DATE, ONE OF THE SUTURES WAS NOT IN ITS PACKAGING AND WAS NOT STERILE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7597743 ↗

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