MONOCRYL MCP923GRecalls & reported problems
Ethicon, LLC · Antibacterial Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture · Class 2 · Implant
All models of MONOCRYL (127)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Ethicon Monocryl suture is an absorbable surgical stitch. Reports mostly describe the needle breaking off or pulling away from the thread during surgery and the thread fraying or not holding, sometimes needing extra surgery to retrieve a piece. There are 26 reports naming its identifier, with no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10705031218611), received between Feb 10, 2021 and Dec 16, 2025 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Break” (17 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.
Reports received per month
Most reported problems
Device problems
- Break17
- Material Separation8
- Material Frayed1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- Wound Dehiscence1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2025Material Separation; Material Separation
IT WAS REPORTED THAT AN ANIMAL UNDERWENT ROUTINE ABDOMINAL SURGERY CLOSURE IN 2025 AND SUTURE WAS USED. THE NEEDLE DETACHED/BROKE OFF FROM THE SUTURE DURING USE. THE NEEDLE BROKE BENEATH THE DERMAL LAYER, REQUIRING THE PATIENT TO BE REOPENED TO RETRIEVE THE FRAGMENT. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23820743 ↗MalfunctionDec 16, 2025Material Separation; Material Separation
IT WAS REPORTED THAT AN ANIMAL UNDERWENT ROUTINE ABDOMINAL SURGERY CLOSURE IN 2025 AND SUTURE WAS USED. THE NEEDLE DETACHED/BROKE OFF FROM THE SUTURE DURING USE. THE NEEDLE BROKE BENEATH THE DERMAL LAYER, REQUIRING THE PATIENT TO BE REOPENED TO RETRIEVE THE FRAGMENT. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23820668 ↗MalfunctionApr 2, 2025Material Frayed; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE INTERRUPTED SUTURES THAT APPEARED NOT TO HOLD AND FRAYED. ONLY 1 OR 2 WAS INTACT WITH SOME FRAYING. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Wound Dehiscence
MAUDE report 21752168 ↗MalfunctionFeb 23, 2024Break; Break
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER REPORTED THAT 2 OF THE PACKS IN THE BOX HAD BENT NEEDLES AND 1 NEEDLE BROKE IN SURGERY. THE CUSTOMER IS UNSURE OF THE IMPACTED PRODUCT BEING AVAILABLE BUT WILL SEND BACK 3 PACKS FOR ANALYSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18767703 ↗MalfunctionFeb 13, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE PULLED OUT OF THE NEEDLE. NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18697017 ↗MalfunctionJul 27, 2023Material Separation; Material Separation
IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. TRIED USING THE SUTURE AND THE NEEDLES FALLING OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17402768 ↗MalfunctionJul 26, 2023Material Separation; Material Separation
IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. TRIED USING THE SUTURE AND THE NEEDLES FALLING OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17400411 ↗MalfunctionJul 26, 2023Material Separation; Material Separation
IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. TRIED USING THE SUTURE AND THE NEEDLES FALLING OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17400407 ↗MalfunctionJul 26, 2023Material Separation; Material Separation
IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. TRIED USING THE SUTURE AND THE NEEDLES FALLING OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17400404 ↗MalfunctionApr 13, 2023Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16734233 ↗MalfunctionOct 27, 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 SEPARATED FROM THE SUTURE THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12704442 ↗MalfunctionOct 27, 2021Break; Break
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BREAKING EASILY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12704425 ↗MalfunctionMar 22, 2021Break; Break
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11548045 ↗MalfunctionMar 22, 2021Break; Break
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11548044 ↗MalfunctionMar 22, 2021Break; Break
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11548042 ↗MalfunctionMar 8, 2021Break; Break
IT WAS REPORTED THAT A DOG UNDERWENT A NEUTER PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WITH THE NORMAL TENSION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11441103 ↗MalfunctionMar 8, 2021Break; Break
IT WAS REPORTED THAT A DOG UNDERWENT A NEUTER PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WITH THE NORMAL TENSION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11441032 ↗MalfunctionMar 8, 2021Break; Break
IT WAS REPORTED THAT A DOG UNDERWENT A NEUTER PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WITH THE NORMAL TENSION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11441030 ↗MalfunctionMar 8, 2021Break; Break
IT WAS REPORTED THAT A DOG UNDERWENT A NEUTER PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WITH THE NORMAL TENSION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11441013 ↗MalfunctionMar 8, 2021Break; Break
IT WAS REPORTED THAT A CAT UNDERWENT A SPAY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WITH THE NORMAL TENSION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11441012 ↗MalfunctionMar 8, 2021Break; Break
IT WAS REPORTED THAT A CAT UNDERWENT A SPAY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WITH THE NORMAL TENSION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11440994 ↗MalfunctionMar 8, 2021Break; Break
IT WAS REPORTED THAT A DOG UNDERWENT A NEUTER PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WITH THE NORMAL TENSION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11440946 ↗MalfunctionMar 4, 2021Break; Break
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE WHEN PULLING THE SKIN TOGETHER. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11415548 ↗MalfunctionFeb 10, 2021Break; Break
IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE EASILY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11312105 ↗MalfunctionFeb 10, 2021Break; Break
IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE EASILY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11312104 ↗
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, ClassifiedMONOCRYL 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 · TerminatedMONOCRYL Plus Antibacterial (poliglecaprone 25) Suture; Ethicon, Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and/o
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- Polysorb CL-915Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID503 reports
- Coated VICRYL VCP493HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID435 reports
- V-Loc 180 VLOCL0316Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall376 reports
- Coated VICRYL VCP345HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death405 reports
- V-Loc 180 VLOCL0604Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall328 reports
- V-Loc 180 VLOCA008LCovidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall294 reports
- V-Loc 180 VLOCL0326Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID330 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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