MONOCRYL Y835GRecalls & 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
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031059702), received between May 17, 2019 and Feb 13, 2026 — classified as 3 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Contamination /Decontamination Problem1
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE NEEDLE BROKE OFF FORM SUTURE TAIL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24337791 ↗MalfunctionMay 8, 2020Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT ARTIFICIAL CERVICAL DISC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN THE PA WAS CLOSING THE SKIN ALONG THE ANTERIOR NECK AND WHILE DRIVING THE NEEDLE, THE NEEDLE BROKE JUST PAST THE SWAGE END. THE PA REPORTED THAT THIS OCCURRED ON MULTIPLE OCCASIONS. THE BROKEN PIECE OF THE NEEDLE WAS RETRIEVED. THERE WAS A DELAY OF ONE MINUTE. A SECOND LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10039776 ↗MalfunctionMay 17, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DEVICE PACKAGE HAD A FLY IN IT. IT IS UNKNOWN WHAT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8620753 ↗
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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