MONOCRYL Y442HRecalls & 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 10705031112711), received between Jul 24, 2024 and Mar 11, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation3
- Break2
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.
MalfunctionMar 11, 2025Break; Break
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2025 AND SUTURE WAS USED. WHEN THE SURGEONS MAKE THE KNOT, THE THREAD BROKE AND FORCES DOCTORS SUTURE AGAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21572140 ↗MalfunctionMar 11, 2025Break; Break
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2025 AND SUTURE WAS USED. WHEN THE SURGEONS MAKE THE KNOT, THE THREAD BROKE AND FORCES DOCTORS SUTURE AGAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21571590 ↗MalfunctionJul 24, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DE-SWAGED WITH ROUTINE USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19817471 ↗MalfunctionJul 24, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DE-SWAGED WITH ROUTINE USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19817463 ↗MalfunctionJul 24, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DE-SWAGED WITH ROUTINE USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19817460 ↗
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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