MONOCRYL Y814GRecalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031059610), received between Sep 2, 2021 and Sep 2, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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.
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2021Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE WHEN PASSING THE SKIN SUTURE. THE PIECE WAS NOT INSIDE THE PATIENT. THE PIECE WAS FOUND OUTSIDE THE SURGICAL FIELD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12419070 ↗
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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