ETHILON 1865GRecalls & reported problems
Ethicon, LLC · Black Monofilament Nylon, Nonabsorbable Surgical Suture · Class 2 · Implant
Quick summary
This ETHICON Ethilon black nylon surgical suture is a nonabsorbable stitch used in procedures. The 39 reports mostly describe the suture separating or splitting from its needle during use; no deaths or injuries were reported. No recalls name this device. Reports rose from 1 in the previous 12 months to 13 in the latest 12 months.
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
- 45
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10705031002838), received between Jul 31, 2019 and Sep 30, 2026 — classified as 45 malfunctions.
The most frequently reported specific device problem is “Material Separation” (33 reports).
8 other recalls cover devices cleared under the same FDA submission (K946173); 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 Separation33
- Defective Component11
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions44
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Separation
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. The suture split from the needle. No adverse patient consequences were reported. Additional information was requested
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946795 ↗MalfunctionSep 25, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902753 ↗MalfunctionSep 25, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902740 ↗MalfunctionSep 24, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889093 ↗MalfunctionSep 24, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889068 ↗MalfunctionAug 12, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50221427 ↗MalfunctionJul 27, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50012015 ↗MalfunctionJul 27, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50012012 ↗MalfunctionJun 12, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SPLIT FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25487933 ↗MalfunctionJun 12, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SPLIT FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25487928 ↗MalfunctionMar 26, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE 5/0 SUTURE SPLIT FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699840 ↗MalfunctionMar 26, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE 5/0 SUTURE SPLIT FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699789 ↗MalfunctionMar 26, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE 5/0 SUTURE SPLIT FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699766 ↗MalfunctionMar 26, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE 5/0 SUTURE SPLIT FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24699717 ↗MalfunctionMar 25, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE FOUND PROBLEMS DURING USE; IT KEPT COMING LOOSE FROM THE NEEDLE WHILE SEWING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24694364 ↗MalfunctionMar 25, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE FOUND PROBLEMS DURING USE; IT KEPT COMING LOOSE FROM THE NEEDLE WHILE SEWING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24694362 ↗MalfunctionMar 25, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(4) 2026 AND SUTURE WAS USED. THE SUTURE FOUND PROBLEMS DURING USE; IT KEPT COMING LOOSE FROM THE NEEDLE WHILE SEWING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24694360 ↗MalfunctionMar 25, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE FOUND PROBLEMS DURING USE; IT KEPT COMING LOOSE FROM THE NEEDLE WHILE SEWING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24694359 ↗MalfunctionMar 25, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURE FOUND PROBLEMS DURING USE; IT KEPT COMING LOOSE FROM THE NEEDLE WHILE SEWING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24694356 ↗MalfunctionJul 18, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A TUMMY TUCK PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER FOUND A BROKEN BETWEEN SWAGE AND SUTURE WHILE UNDERGOING SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22543134 ↗MalfunctionSep 24, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTOPEXY ON (B)(6) 2024 AND SUTURE WAS USED FOR CLOSURE OF THE WOUND. DURING THE PROCEDURE, THE NEEDLE BROKE OFF THE SUTURE. THE SUTURE WAS BEING HANDLED IN A NORMAL FASHION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20296197 ↗MalfunctionSep 24, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTOPEXY ON (B)(6) 2024 AND SUTURE WAS USED FOR CLOSURE OF THE WOUND. DURING THE PROCEDURE, THE NEEDLE BROKE OFF THE SUTURE. THE SUTURE WAS BEING HANDLED IN A NORMAL FASHION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20295545 ↗MalfunctionSep 24, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTOPEXY ON (B)(6) 2024 AND SUTURE WAS USED FOR CLOSURE OF THE WOUND. DURING THE PROCEDURE, THE NEEDLE BROKE OFF THE SUTURE. THE SUTURE WAS BEING HANDLED IN A NORMAL FASHION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20295505 ↗MalfunctionSep 24, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTOPEXY ON (B)(6) 2024 AND SUTURE WAS USED FOR CLOSURE OF THE WOUND. DURING THE PROCEDURE, THE NEEDLE BROKE OFF THE SUTURE. THE SUTURE WAS BEING HANDLED IN A NORMAL FASHION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20295500 ↗MalfunctionSep 24, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTOPEXY ON (B)(6) 2024 AND SUTURE WAS USED FOR CLOSURE OF THE WOUND. DURING THE PROCEDURE, THE NEEDLE BROKE OFF THE SUTURE. THE SUTURE WAS BEING HANDLED IN A NORMAL FASHION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20295498 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K946173. One submission often covers many models, so check the product and lot details in each record.
- Z-1516-2025 · Mar 7, 2025 · Open, ClassifiedETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
- Z-1097-2025 · Dec 20, 2024 · Open, ClassifiedPERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovas
- Z-2486-2020 · Jun 10, 2020 · Open, ClassifiedPERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870
- Z-1841-2019 · Apr 19, 2019 · TerminatedETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue app
- Z-1842-2019 · Apr 19, 2019 · TerminatedETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue appr
- Z-0747-2019 · Dec 18, 2018 · TerminatedPERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approxima
- Z-1839-2015 · May 8, 2015 · TerminatedEthicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. Fast ab
- Z-0492-2015 · Oct 17, 2014 · TerminatedEthicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE devices
- ETHILON 697GEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE223 reports
- ETHILON 698GEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE119 reports
- ETHILON 1696GEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE118 reports
- Monosof SN-3695Covidien LP · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 recalls3 reports
- McKesson S931BXMckesson Medical-Surgical Inc. · Suture, Nonabsorbable, Synthetic, Polyamide2 recalls2 reports
- McKesson S661GXMckesson Medical-Surgical Inc. · Suture, Nonabsorbable, Synthetic, Polyamide2 recalls2 reports
- Surgilon 88861919-41Covidien LP · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 recalls2 reports
- McKesson S697GXMckesson Medical-Surgical Inc. · Suture, Nonabsorbable, Synthetic, Polyamide2 recalls1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.