ETHILON 1698GRecalls & reported problems
Ethicon, LLC · Black Monofilament Nylon, Nonabsorbable Surgical Suture · Class 2 · Implant
Quick summary
This Ethicon Ethilon nylon surgical suture is used to close tissue during surgery. The 37 reports mostly describe the thread breaking or separating, fraying, and needles popping off the suture, plus a few instances of the suture arriving contaminated. No deaths or injuries are described. There are no recalls naming this device. Reports rose from 2 in the prior 12 months to 10 in the most recent 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
- 37
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10705031002180), received between Jul 17, 2019 and Apr 21, 2026 — classified as 37 malfunctions.
The most frequently reported specific device problem is “Break” (21 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
- Break21
- Material Separation11
- Device Contaminated During Manufacture or Shipping3
- Material Frayed2
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- No Consequences Or Impact To Patient9
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE NEEDLE POPPED OFF THE THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24939344 ↗MalfunctionApr 21, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE NEEDLE POPPED OFF THE THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24939343 ↗MalfunctionApr 21, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE NEEDLE POPPED OFF THE THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24939341 ↗MalfunctionApr 21, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE NEEDLE POPPED OFF THE THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24939339 ↗MalfunctionApr 21, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE NEEDLE POPPED OFF THE THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24939338 ↗MalfunctionApr 21, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE NEEDLE POPPED OFF THE THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24939337 ↗MalfunctionApr 21, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE NEEDLE POPPED OFF THE THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24939336 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT NEEDLES ARE POPPING OFF THE SUTURE VERY EASILY. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24052391 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT NEEDLES ARE POPPING OFF THE SUTURE VERY EASILY. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24052390 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT NEEDLES ARE POPPING OFF THE SUTURE VERY EASILY. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24052388 ↗MalfunctionDec 10, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A BLEPHAROPTOSIS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING CONTINUOUS SUTURING, THE SUTURE WAS BROKEN WHEN USING. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20895915 ↗MalfunctionDec 10, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A BLEPHAROPTOSIS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING CONTINUOUS SUTURING, THE SUTURE WAS BROKEN WHEN USING. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20895861 ↗MalfunctionOct 28, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A BLEPHAROPTOSIS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING CONTINUOUS SUTURING, THE SUTURE WAS BROKEN WHEN USING. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20550908 ↗MalfunctionSep 24, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS NOT A CONTROL RELEASE NEEDLE. IT WAS FOUND THAT THERE HAD BEEN A FOREIGN MATTER IN THE PACKAGE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20292689 ↗MalfunctionSep 15, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON 20-AUG-2024 AND SUTURE WAS USED. IT WAS FOUND THAT THERE HAD BEEN A FOREIGN MATTER IN THE STERILIZATION PACKAGE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20221278 ↗MalfunctionAug 25, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20061109 ↗MalfunctionAug 25, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20061108 ↗MalfunctionAug 25, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20061107 ↗MalfunctionJul 18, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER IS REPORTING THAT THEY RECEIVED A DAMAGED BOXES AND WHEN THEY WENT TO USE SUTURE THAT IT WAS FALLING APART BEFORE ANY PRESSURE WOULD BE APPLIED TO THEM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19778816 ↗MalfunctionJul 15, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER IS REPORTING THAT THEY RECEIVED A DAMAGED BOXES AND WHEN THEY WENT TO USE SUTURE THAT IT WAS FALLING APART BEFORE ANY PRESSURE WOULD BE APPLIED TO THEM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19746727 ↗MalfunctionJun 17, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A PLASTIC SURGERY, THE SUTURE WAS BROKEN EASILY. IT WAS OCCURRED 2 PACKAGES IN A ROW. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19549599 ↗MalfunctionJun 17, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A PLASTIC SURGERY, THE SUTURE WAS BROKEN EASILY. IT WAS OCCURRED 2 PACKAGES IN A ROW. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19549568 ↗MalfunctionMay 7, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON 23-APRIL-2024 AND SUTURE WAS USED. IT WAS FOUND THAT THE SUTURE HAD FOREIGN MATTER PRESENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19260643 ↗MalfunctionNov 27, 2023Break; Break
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE NEEDLE BROKE WHEN IN USE. NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18212553 ↗MalfunctionNov 27, 2023Break; Break
IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE NEEDLE BROKE WHEN IN USE. NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18212552 ↗
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-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-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-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.