MONOCRYL Y946HRecalls & reported problems
Ethicon, LLC · Undyed 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
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031059979), received between Mar 22, 2023 and Sep 4, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (3 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
- Delivered as Unsterile Product3
- Break1
- Device Markings/Labelling Problem1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2025Material Separation; Device Markings/Labelling Problem; Material Separation; Device Markings/Labelling Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT, THERE IS NO BARCODE IN THE PACKAGE, AND THE NEEDLE IS DETACHING DURING SUTURING, CAUSING IT TO POP. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22967365 ↗MalfunctionSep 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL, THAT FOUND HOLE IN THE SUTURE. THERE WAS NO PATIENT CONSEQUENCE WAS REPORTED. THE DEVICE WAS AVAILABLE FOR RETURN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20251885 ↗MalfunctionJun 1, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY THE FACILITY ¿FOUND HOLES IN SUTURE PACKETS¿ NO PATIENT INJURY WAS REPORTED. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17038506 ↗MalfunctionJun 1, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY THE FACILITY ¿FOUND HOLES IN SUTURE PACKETS¿ NO PATIENT INJURY WAS REPORTED. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17038504 ↗MalfunctionMar 22, 2023Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A GYN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE NEEDLE BROKE OFF IN THE UTERUS. IT WAS RETRIEVED AND A NEW SUTURE WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16593676 ↗
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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