MONOCRYL Y433HRecalls & reported problems
Ethicon, LLC · Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Ethicon Monocryl absorbable surgical suture is a clear monofilament stitch used to close wounds. The 27 reports mostly describe the thread separating or breaking, and the needle pulling off the suture mid-operation, sometimes slowing or interrupting closing. Six reports involved injuries, and no deaths were reported. 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
- 28
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10705031059184), received between Feb 12, 2018 and Sep 23, 2026 — classified as 6 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Material Separation” (14 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation14
- Break7
- Adverse Event Without Identified Device or Use Problem6
- Detachment Of Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- Wound Dehiscence6
- No Consequences Or Impact To Patient3
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873348 ↗MalfunctionMar 3, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT THYROIDECTOMY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. AT 12:56, WHEN THE DOCTOR WAS SUTURING WITH A SUTURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, AND THE SUTURE WAS IMMEDIATELY REPLACED FOR SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24498784 ↗MalfunctionJan 30, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, THE SUTURE BREAKAGE DURING USE WAS MORE NOTICEABLE THAN USUAL. BOTH OF PRODUCTS WERE NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE OF BOTH PRODUCTS WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24221188 ↗MalfunctionJan 30, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, THE SUTURE BREAKAGE DURING USE WAS MORE NOTICEABLE THAN USUAL. BOTH OF PRODUCTS WERE NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE OF BOTH PRODUCTS WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24221186 ↗MalfunctionSep 12, 2025Material Separation; Material Separation
IT WAS REPORTED A PATIENT UNDERWENT A AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. DURING THE SURGICAL SUTURE PROCESS, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED, RESULTING IN A SUTURE ADVERSE EVENT THAT AFFECTED THE PROGRESS OF THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23040260 ↗MalfunctionAug 27, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UROLOGICAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE UPON WOUND SUTURING AFFECTING THE SURGICAL SUTURING PROCESS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22904108 ↗MalfunctionJul 25, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. 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 22609815 ↗MalfunctionJul 25, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON 5/30/2025 AND A SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. 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 22609772 ↗MalfunctionMay 6, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN THE DOCTOR TRIED TO USE IT, THEY PULLED IT AND IT WAS BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19247675 ↗MalfunctionApr 8, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPHTHALMIC PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SEPARATED FROM THE NEEDLE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19061844 ↗MalfunctionApr 8, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPHTHALMIC PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SEPARATED FROM THE NEEDLE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19061841 ↗MalfunctionMar 26, 2024Material Separation; Material Separation
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPY PROCEDURE ON 6-MARCH-2024, AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO PATIENT CONSEQUENCE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18978525 ↗MalfunctionJul 28, 2023Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE KEPT POPPING OFF AND ITS NOT A CONTROL/RELEASE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17419692 ↗MalfunctionJul 13, 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 THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN THE SURGEON ATTEMPTED TO SEW HAND WOUND AT THE FIRST STITCH. CAUSING SLIGHT BLEEDING IN THE PATIENT. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 17316227 ↗MalfunctionJul 11, 2023Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17300233 ↗MalfunctionJul 11, 2023Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE UNKNOWN PROCEDURE, THE NEEDLE WAS BROKEN AT THE SWAGE PART. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17299627 ↗InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SIX TO SEVEN WEEKS POST-OP, PART OF THE WOUND HEALED AND THE OTHER PART DEHISCED. THE PATIENT IS NOW DOING FINE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Wound Dehiscence
MAUDE report 16527064 ↗InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SIX TO SEVEN WEEKS POST-OP, PART OF THE WOUND HEALED AND THE OTHER PART DEHISCED. THE PATIENT IS NOW DOING FINE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Wound Dehiscence
MAUDE report 16527006 ↗InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SIX TO SEVEN WEEKS POST-OP, PART OF THE WOUND HEALED AND THE OTHER PART DEHISCED. THE PATIENT IS NOW DOING FINE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Wound Dehiscence
MAUDE report 16526747 ↗InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SIX TO SEVEN WEEKS POST-OP, PART OF THE WOUND HEALED AND THE OTHER PART DEHISCED. THE PATIENT IS NOW DOING FINE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Wound Dehiscence
MAUDE report 16526545 ↗InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SIX TO SEVEN WEEKS POST-OP, PART OF THE WOUND HEALED AND THE OTHER PART DEHISCED. THE PATIENT IS NOW DOING FINE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Wound Dehiscence
MAUDE report 16526544 ↗InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SIX TO SEVEN WEEKS POST-OP, PART OF THE WOUND HEALED AND THE OTHER PART DEHISCED. THE PATIENT IS NOW DOING FINE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Wound Dehiscence
MAUDE report 16526541 ↗MalfunctionAug 30, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15325398 ↗MalfunctionJun 16, 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 NEEDLE WAS DETACHED FROM THE SUTURE EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14718883 ↗MalfunctionJun 11, 2021Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULOPERITONEAL SHUNT SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURE DETACHED FROM THE NEEDLE DURING DERMOSTITCH. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11982932 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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