ETHILON 1667GRecalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10705031001817), received between Sep 5, 2018 and Sep 28, 2026 — classified as 3 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Break” (23 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Frayed

  It was reported that a patient underwent a hand surgery on an unknown date and suture was used. During Hand Surgery, doctor has had two occasions where the line was frayed. Patient was not affected by suture. The frayed suture was detected by the surgeon and did not provide a significant delay in the procedure. It is a very small section of about 4 mm that was damaged, so the surgeon was able to work around it. They opened a few other sutures from the same lot number and did find others that were damaged. No Patient or End-User was Injured. Device is not available for return. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916700 ↗
• MalfunctionSep 28, 2026Material Frayed

  It was reported that a patient underwent a hand surgery on an unknown date and suture was used. During Hand Surgery, doctor has had two occasions where the line was frayed. Patient was not affected by suture. The frayed suture was detected by the surgeon and did not provide a significant delay in the procedure. It is a very small section of about 4 mm that was damaged, so the surgeon was able to work around it. They opened a few other sutures from the same lot number and did find others that were damaged. No Patient or End-User was Injured. Device is not available for return. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916699 ↗
• MalfunctionSep 28, 2026Material Frayed

  It was reported that a patient underwent a hand surgery on an unknown date and suture was used. During Hand Surgery, doctor has had two occasions where the line was frayed. Patient was not affected by suture. The frayed suture was detected by the surgeon and did not provide a significant delay in the procedure. It is a very small section of about 4 mm that was damaged, so the surgeon was able to work around it. They opened a few other sutures from the same lot number and did find others that were damaged. No Patient or End-User was Injured. Device is not available for return. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916697 ↗
• MalfunctionSep 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916527 ↗
• MalfunctionSep 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916526 ↗
• MalfunctionSep 22, 2026Material Frayed

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860482 ↗
• MalfunctionSep 22, 2026Material Frayed

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860469 ↗
• MalfunctionSep 22, 2026Material Frayed

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860461 ↗
• MalfunctionJan 8, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE CUSTOMER THAT THEY PURCHASED TWO BOXES OF NYLON SUTURE AND NOTICE THAT THE TWO HAD A DIFFERENT LABELS ON WITH NYLON AND OTHER ONE WAS POLYAMIDE 6. HE WAS ASKING IF THE TWO HAD A SAME COMPOSITION SINCE THE PRODUCT CODE ARE THE SAME. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004475 ↗
• MalfunctionJan 8, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE CUSTOMER THAT THEY PURCHASED TWO BOXES OF NYLON SUTURE AND NOTICE THAT THE TWO HAD A DIFFERENT LABELS ON WITH NYLON AND OTHER ONE WAS POLYAMIDE 6. HE WAS ASKING IF THE TWO HAD A SAME COMPOSITION SINCE THE PRODUCT CODE ARE THE SAME. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004474 ↗
• MalfunctionDec 12, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT 2 NEEDLES FOUND ON THE SUTURE JOINED TOGETHER, WHEN THERE SHOULD ONLY BE ONE THIS SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794685 ↗
• MalfunctionNov 7, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE PRODUCT WAS SUPPOSED TO BE A SINGLE-ARMED SUTURE, BUT IT WAS A DOUBLE-ARMED SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500683 ↗
• MalfunctionNov 7, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE PRODUCT WAS SUPPOSED TO BE A SINGLE-ARMED SUTURE, BUT IT WAS A DOUBLE-ARMED SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500679 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A SKIN REACTION A WEEK OR TWO WEEKS AFTER THE PROCEDURE. THE PATIENT HAD SWELLING AND THE SKIN WAS RAISED WITH A LITTLE BIT OF DRAINAGE. THE PATIENTS WAS TREATED WITH ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 21503894 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A SKIN REACTION A WEEK OR TWO WEEKS AFTER THE PROCEDURE. THE PATIENT HAD SWELLING AND THE SKIN WAS RAISED WITH A LITTLE BIT OF DRAINAGE. THE PATIENTS WAS TREATED WITH ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 21503892 ↗
• InjuryDec 2, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, SURGEON REPORTED THAT THE SUTURE BROKE WITH THE KNOTS INTACT. THE BREAK RESULTED IN THE PATIENT'S WOUND OPENING UP. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 20821387 ↗
• MalfunctionDec 2, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, SURGEON REPORTED THAT THE SUTURE BROKE WITH THE KNOTS INTACT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20821360 ↗
• MalfunctionJun 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE DEVICE BROKE BETWEEN THE NEEDLE AND THE THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19605420 ↗
• MalfunctionJun 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE DEVICE BROKE BETWEEN THE NEEDLE AND THE THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19605393 ↗
• MalfunctionJun 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE DEVICE BROKE BETWEEN THE NEEDLE AND THE THREAD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19605391 ↗
• MalfunctionJun 10, 2024Break; Break

  IT WAS REPORTED THAT PATIENTS UNDERWENT MASTOPEXY BREAST SURGERY AND ABDOMINOPLASTIES ON (B)(6) 2024, AND SUTURE WAS USED. DURING PROCEDURES, THE NEEDLES WERE BREAKING OFF. THEY ARE BREAKING AFTER THE SURGEON PASSES THROUGH THE SKIN AND GOES TO GRAB THE NEEDLE TO PULL IT THROUGH. AS HE IS PULLING IT THROUGH, THE NEEDLE SNAPS OFF WITH ANY TENSION ON IT. THE SURGEON HASN¿T CHANGED HOW HE IS USING THE SUTURE OR TYING THE KNOTS. THE FACILITY JUST RECEIVED A NEW BOX AND IT IS ALREADY GONE AS THEY ALL BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19506148 ↗
• MalfunctionJun 10, 2024Break; Break

  IT WAS REPORTED THAT PATIENTS UNDERWENT MASTOPEXY BREAST SURGERY AND ABDOMINOPLASTIES ON (B)(6) 2024, AND SUTURE WAS USED. DURING PROCEDURES, THE NEEDLES WERE BREAKING OFF. THEY ARE BREAKING AFTER THE SURGEON PASSES THROUGH THE SKIN AND GOES TO GRAB THE NEEDLE TO PULL IT THROUGH. AS HE IS PULLING IT THROUGH, THE NEEDLE SNAPS OFF WITH ANY TENSION ON IT. THE SURGEON HASN¿T CHANGED HOW HE IS USING THE SUTURE OR TYING THE KNOTS. THE FACILITY JUST RECEIVED A NEW BOX AND IT IS ALREADY GONE AS THEY ALL BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19506127 ↗
• MalfunctionJun 10, 2024Break; Break

  IT WAS REPORTED THAT PATIENTS UNDERWENT MASTOPEXY BREAST SURGERY AND ABDOMINOPLASTIES ON (B)(6) 2024, AND SUTURE WAS USED. DURING PROCEDURES, THE NEEDLES WERE BREAKING OFF. THEY ARE BREAKING AFTER THE SURGEON PASSES THROUGH THE SKIN AND GOES TO GRAB THE NEEDLE TO PULL IT THROUGH. AS HE IS PULLING IT THROUGH, THE NEEDLE SNAPS OFF WITH ANY TENSION ON IT. THE SURGEON HASN¿T CHANGED HOW HE IS USING THE SUTURE OR TYING THE KNOTS. THE FACILITY JUST RECEIVED A NEW BOX AND IT IS ALREADY GONE AS THEY ALL BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19506124 ↗
• MalfunctionJun 10, 2024Break; Break

  IT WAS REPORTED THAT PATIENTS UNDERWENT MASTOPEXY BREAST SURGERY AND ABDOMINOPLASTIES ON (B)(6)2024, AND SUTURE WAS USED. DURING PROCEDURES, THE NEEDLES WERE BREAKING OFF. THEY ARE BREAKING AFTER THE SURGEON PASSES THROUGH THE SKIN AND GOES TO GRAB THE NEEDLE TO PULL IT THROUGH. AS HE IS PULLING IT THROUGH, THE NEEDLE SNAPS OFF WITH ANY TENSION ON IT. THE SURGEON HASN¿T CHANGED HOW HE IS USING THE SUTURE OR TYING THE KNOTS. THE FACILITY JUST RECEIVED A NEW BOX AND IT IS ALREADY GONE AS THEY ALL BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505581 ↗
• MalfunctionJun 10, 2024Break; Break

  IT WAS REPORTED THAT PATIENTS UNDERWENT MASTOPEXY BREAST SURGERY AND ABDOMINOPLASTIES ON (B)(6) 2024, AND SUTURE WAS USED. DURING PROCEDURES, THE NEEDLES WERE BREAKING OFF. THEY ARE BREAKING AFTER THE SURGEON PASSES THROUGH THE SKIN AND GOES TO GRAB THE NEEDLE TO PULL IT THROUGH. AS HE IS PULLING IT THROUGH, THE NEEDLE SNAPS OFF WITH ANY TENSION ON IT. THE SURGEON HASN¿T CHANGED HOW HE IS USING THE SUTURE OR TYING THE KNOTS. THE FACILITY JUST RECEIVED A NEW BOX AND IT IS ALREADY GONE AS THEY ALL BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505552 ↗

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, Classified
  ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
• Z-1097-2025 · Dec 20, 2024 · Open, Classified
  PERMA-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, Classified
  PERMA-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 · Terminated
  ETHIBOND 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 · Terminated
  ETHIBOND 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 · Terminated
  PERMA-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 · Terminated
  Ethicon 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 · Terminated
  Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.