MONOCRYL Y432HRecalls & reported problems
Ethicon, LLC · 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 absorbable surgical suture is a violet monofilament thread used to close wounds. The 51 reports mostly describe the needle pulling off or breaking away from the suture during surgery, and the thread material separating, so staff had to swap in another suture to finish closing. No deaths and no injuries were reported, and 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
- 53
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10705031059177), received between Feb 26, 2019 and Sep 29, 2026 — classified as 53 malfunctions.
The most frequently reported specific device problem is “Material Separation” (41 reports).
2 other recalls cover devices cleared under the same FDA submission (K964072); 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
- Material Separation41
- Break12
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- No Consequences Or Impact To Patient11
- Unspecified Tissue Injury1
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932997 ↗MalfunctionAug 6, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50165146 ↗MalfunctionMay 8, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE THE NURSE FOUND THAT THE NEEDLE PULL OFF ISSUE HAPPENED WHILE USING IT AND REPLACED IT WITH A NEW SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25128378 ↗MalfunctionFeb 26, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXTERNAL GENITAL PLASTIC PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. AT 15:00, THE DOCTOR FOUND THAT THE NEEDLE OF THE SUTURE HAD FALLEN OFF WHILE PERFORMING SURGERY ON THE PATIENT. IMMEDIATELY REPLACED THE SUTURE WITH A NEW ONE AND SUCCESSFULLY COMPLETED THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461099 ↗MalfunctionFeb 5, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24272141 ↗MalfunctionFeb 5, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24272010 ↗MalfunctionDec 18, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A LACERATION CLOSURE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23840411 ↗MalfunctionDec 16, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN CLOSURE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING THE SURGERY. THE NEEDLE DID NOT FALL INTO THE PATIENT. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23821016 ↗MalfunctionDec 16, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN CLOSURE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING THE SURGERY. THE NEEDLE DID NOT FALL INTO THE PATIENT. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23820906 ↗MalfunctionDec 1, 2025Material Separation; Material Separation
IT WAS REPORTED THA TA PATIENT UNDERWENT A FINGER ABDOMINAL SKIN LACERATION SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23682522 ↗MalfunctionAug 27, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT URETHRAL FISTULA REPAIR SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT UNDERWENT SURGERY AT THE HOSPITAL DUE TO URETHRAL FISTULA. AT 14:30 DURING THE OPERATION, THE DOCTOR SUTURED AND KNOTTED THE KNOT, AND THE TAIL END OF THE SUTURE BROKE BY 5 CENTIMETERS. THE DOCTOR CUT OFF 3 CENTIMETERS OF THE BROKEN SUTURE AND CONTINUED TO COMPLETE THE SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22906247 ↗MalfunctionAug 4, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE DOCTOR WAS SUTURING THE WOUND, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. UPON DISCOVERY, THE DOCTOR IMMEDIATELY REPLACED THE SUTURE FOR WOUND SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22701264 ↗MalfunctionJul 28, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING IN SURGERY. CHANGED TO 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 22629647 ↗MalfunctionJul 17, 2025Material Separation; Material Separation
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. THE CHILD WAS ADMITTED TO THE HOSPITAL DUE TO "RIGHT EYEBROW TRAUMA". THE SKIN TEAR WAS SUTURED WITH SUTURE. BEFORE SUTURING, THE SUTURE AND THE NEEDLE WERE CONNECTED INTACT. AFTER ONE STITCH, THE SUTURE WAS FOUND TO HAVE FALLEN OFF, AND ONLY THE NEEDLE PASSED THROUGH THE WOUND. A NEW PACKAGE OF SUTURE WAS OPENED TO SUTURE THE CHILD, CAUSING SECONDARY INJURY TO THE PATIENT.
Patient problems: Unspecified Tissue Injury
MAUDE report 22531597 ↗MalfunctionJan 14, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A MULTI FINGER SURGICAL RESECTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT UNDERWENT SURGICAL RESECTION DUE TO MULTIPLE FINGERS. DURING THE OPERATION, SUTURE WAS USED FOR SUTURING, BUT AFTER OPENING THE PACKAGE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED AND COULD NOT BE USED NORMALLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21148901 ↗MalfunctionJan 7, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACIAL TRAUMA PLASTIC SURGERY AND REPAIR PROCEDURE DUE TO FACIAL LACERATIONS ON (B)(6)2024 AND SUTURE WAS USED TO SUTURE THE PATIENT'S SUBCUTANEOUS LAYER. WHEN SEWING DURING THE SURGERY THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. 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 21096309 ↗MalfunctionDec 11, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THE NEEDLE POPPED OFF SUTURE AS IF IT WERE A CONTROL RELEASE SUTURE. THERE WAS NO PATIENT CONSEQUENCES REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20908453 ↗MalfunctionDec 4, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20844007 ↗MalfunctionNov 1, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT ORAL AND MAXILLOFACIAL DEBRIDEMENT AND SUTURING SURGERY DUE TO A 3-HOUR SKIN LACERATION IN THE LOWER JAW ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE SUTURING PROCESS, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, AND REPLACED THE SUTURE WITH A NEW ONE TO CONTINUE SUTURING. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20588783 ↗MalfunctionOct 16, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED DUE TO FACIAL TRAUMA. THE DOCTOR PERFORMED FACIAL DEBRIDEMENT AND SUTURING ON THE PATIENT'S FACE. DURING THE PROCESS OF REMOVING THE SUTURE, THE INTEGRATED NEEDLE BROKE, WHICH MAY POSE A RISK OF INFECTION. IMMEDIATELY REPLACE THE SUTURE AFTER THE INCIDENT AND CONTINUE TO SUTURE THE PATIENT AFTER CHECKING FOR ACCURACY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20467613 ↗MalfunctionOct 14, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CIRCUMCISION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE DURING THE WOUND SUTURING PROCESS. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20440605 ↗MalfunctionAug 12, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE PATIENT HAD A CONCEALED PENIS AND UNDERWENT SURGERY. DURING THE SUTURING PROCESS, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. COINCIDENTALLY, THE PATIENT RECEIVED THE LAST STITCH AND DID NOT NEED TO REPLACE IT. THE SUTURE WAS KNOTTED AND THE SURGERY WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19965995 ↗MalfunctionAug 6, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19923850 ↗MalfunctionJun 17, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT DURING SURGERY, PULL OFF SUTURE NEEDLE OCCURRED DURING SEWING THE SUBCUTANEOUS TISSUE OF SCROTAL SKIN. X RAY WAS PERFORMED FOR 2 TIMES TO LOOK FOR THE NEEDLE BUT NOT FOUND. THE SURGEON THEN CONTINUED TO COMPLETE THE SURGERY. THE PATIENT IS CURRENTLY STABLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19549168 ↗MalfunctionMar 8, 2024Material Separation; Material Separation
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. THE SURGEON CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT OF PATIENT INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18865909 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K964072. One submission often covers many models, so check the product and lot details in each record.
- Z-0487-2025 · Oct 8, 2024 · Open, ClassifiedMONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and
- Z-2148-2024 · May 10, 2024 · Open, ClassifiedMONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345
Other SUTURE, ABSORBABLE, SYNTHETIC devices
- MONOCRYL Y426HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC141 reports
- MONOCRYL Y936HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC1 recall66 reports
- MONOCRYL Y923HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC111 reports
- MONOCRYL Y427HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC1 recall53 reports
- MONOCRYL Y496GEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC86 reports
- MONOCRYL Y943GEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC77 reports
- MONOCRYL Y416HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC1 recall13 reports
- MONOCRYL Y935HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC1 recall8 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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