ETHILON 1666HRecalls & reported problems
Ethicon, LLC · Black Monofilament Nylon, Nonabsorbable Surgical Suture · Class 2 · Implant
All models of ETHILON (133)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Ethicon black nylon monofilament surgical suture is a nonabsorbable stitching thread used to close wounds. Reports mostly describe the suture material separating or pulling apart, and in one case coming off the needle during a face-lift procedure. There are 36 reports, with no deaths and no injuries, and no recalls name this device. All 30 of these reports came in the past 12 months, after none in the prior12 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
- 36
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10705031001794), received between Jun 15, 2021 and Jan 13, 2026 — classified as 36 malfunctions.
The most frequently reported specific device problem is “Material Separation” (36 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation36
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions36
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058633 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058630 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058617 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058602 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058601 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058599 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058582 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058573 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058542 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058540 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058532 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058530 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058503 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058501 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058498 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058495 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058494 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058318 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058294 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058287 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058285 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058283 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT (RHYTIDECTOMY) ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058234 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT (RHYTIDECTOMY) ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058231 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A FACE LIFT (RHYTIDECTOMY) ON 17-DEC2025 AND SUTURE WAS USED. IT WAS REPORTED BY THE NURSE THAT DURING A FACE LIFT PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058223 ↗
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 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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