ETHILON 697GRecalls & reported problems
Ethicon, LLC · Black Monofilament Nylon, Nonabsorbable Surgical Suture · Class 2 · Implant
Quick summary
This Ethicon Ethilon 697G is a black nylon nonabsorbable surgical suture. Most reports describe the thread breaking during surgery, with a smaller number describing the material separating. There are 66 reports, with no deaths and no injuries. Reports rose sharply in the past 12 months, from 5 to 31. No recalls name this device.
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
- 223
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 223 adverse event reports that list this exact device (DI 10705031008540), received between Dec 22, 2017 and Sep 22, 2026 — classified as 223 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (80 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
- Appropriate Device Problem Term/Code Not Available157
- Material Deformation80
- Material Twisted/Bent77
- Break55
- Material Separation10
- Dull, Blunt6
- Component Misassembled1
- Delivered as Unsterile Product1
Patient problems
- No Clinical Signs, Symptoms or Conditions200
- No Consequences Or Impact To Patient22
- Not Applicable2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 223 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860064 ↗MalfunctionSep 22, 2026Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. It was reported by a sales rep that, during an unknown plastic surgery, the doctors felt something wrong when 697G was used. The needle at the proximal end was unusually bent. A few needles were used from the same box, but they all seemed to be unusually bent. It was not a control release needle. Another product was used to complete the case. There were no adverse consequences to the patient. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860056 ↗MalfunctionSep 22, 2026Material Deformation; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859858 ↗MalfunctionSep 22, 2026Material Deformation; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859781 ↗MalfunctionSep 22, 2026Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859776 ↗MalfunctionSep 22, 2026Material Deformation; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859754 ↗MalfunctionSep 22, 2026Material Deformation; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859751 ↗MalfunctionSep 22, 2026Material Deformation; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859748 ↗MalfunctionSep 22, 2026Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859710 ↗MalfunctionSep 22, 2026Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859708 ↗MalfunctionSep 22, 2026Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859703 ↗MalfunctionSep 22, 2026Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859702 ↗MalfunctionSep 22, 2026Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859696 ↗MalfunctionSep 22, 2026Material Deformation; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859082 ↗MalfunctionSep 22, 2026Material Deformation; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859079 ↗MalfunctionSep 22, 2026Material Deformation; Appropriate Device Problem Term/Code Not Available
It was reported that a patient underwent an unknown plastic surgery procedure on (b)(6) 2026 and suture was used. It was reported, before an unknown plastic surgery, the issue was discovered when tried to use the product. Out of the entire box (containing 12 packages), two packs had already been opened. The plastic at the bottom was bent where the green stripe was cut, and the needle was pointing upwards. The same condition is visible from the outside on the remaining 10 packages. As the distribution agency has confirmed at hand that all products are bent, the product involved is reported the entire 12 packages. The product was not used for the patient. It was not a control release needle. Another product was used to complete the case. There were no adverse consequences to the patient. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859075 ↗MalfunctionSep 22, 2026Material Deformation; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859074 ↗MalfunctionSep 22, 2026Material Deformation; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859063 ↗MalfunctionSep 22, 2026Material Deformation; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859057 ↗MalfunctionSep 22, 2026Material Deformation; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859055 ↗MalfunctionSep 22, 2026Material Deformation; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859053 ↗MalfunctionSep 22, 2026Material Deformation; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859051 ↗MalfunctionSep 22, 2026Material Deformation; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859048 ↗MalfunctionSep 22, 2026Material Deformation; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859043 ↗MalfunctionSep 22, 2026Material Deformation; Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859029 ↗
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 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
- McKesson S913BXMckesson Medical-Surgical Inc. · Suture, Nonabsorbable, Synthetic, Polyamide2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.