ETHILON 698GRecalls & reported problems

Summary

The FDA's MAUDE database contains 119 adverse event reports that list this exact device (DI 10705031008588), received between Apr 30, 2018 and Jul 15, 2026 — classified as 119 malfunctions.

The most frequently reported specific device problem is “Material Separation” (58 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 119 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25826360 ↗
• MalfunctionJun 10, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL EXCISION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE ACCOUNT CONTACT THAT DURING A SURGICAL EXCISION UNDER FROZEN SECTION PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25462771 ↗
• MalfunctionJun 10, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL EXCISION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE ACCOUNT CONTACT THAT DURING A SURGICAL EXCISION UNDER FROZEN SECTION PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE. NO ADDITIONAL INFORMATION PROVIDED. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25462746 ↗
• MalfunctionJun 10, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MINI FACELIFT PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE ACCOUNT CONTACT THAT DURING A MINI FACELIFT PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE. NO ADDITIONAL INFORMATION PROVIDED. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25462741 ↗
• MalfunctionJun 10, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MINI FACELIFT PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE ACCOUNT CONTACT THAT DURING A MINI FACELIFT PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE. NO ADDITIONAL INFORMATION PROVIDED. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25462701 ↗
• MalfunctionJun 10, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MINI FACELIFT PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE ACCOUNT CONTACT THAT DURING A MINI FACELIFT PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE. NO ADDITIONAL INFORMATION PROVIDED. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25462691 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN EASILY DURING LIGATION. EIGHT OUT OF TWELVE SUTURES WERE BROKEN IN A ROW. 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 25085636 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN EASILY DURING LIGATION. EIGHT OUT OF TWELVE SUTURES WERE BROKEN IN A ROW. 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 25085623 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN EASILY DURING LIGATION. EIGHT OUT OF TWELVE SUTURES WERE BROKEN IN A ROW. 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 25085620 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN EASILY DURING LIGATION. EIGHT OUT OF TWELVE SUTURES WERE BROKEN IN A ROW. 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 25085613 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN EASILY DURING LIGATION. EIGHT OUT OF TWELVE SUTURES WERE BROKEN IN A ROW. 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 25085603 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN EASILY DURING LIGATION. EIGHT OUT OF TWELVE SUTURES WERE BROKEN IN A ROW. 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 25085600 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN EASILY DURING LIGATION. EIGHT OUT OF TWELVE SUTURES WERE BROKEN IN A ROW. 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 25085597 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN EASILY DURING LIGATION. EIGHT OUT OF TWELVE SUTURES WERE BROKEN IN A ROW. 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 25085595 ↗
• 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 24939342 ↗
• MalfunctionApr 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN THEY RETURNED TO SURGERY THEY HAD GONE THROUGH ALL THREE BOXES QUICKLY BECAUSE THE NEEDLES POPPED OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926690 ↗
• MalfunctionApr 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN THEY RETURNED TO SURGERY THEY HAD GONE THROUGH ALL THREE BOXES QUICKLY BECAUSE THE NEEDLES POPPED OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926661 ↗
• MalfunctionApr 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN THEY RETURNED TO SURGERY THEY HAD GONE THROUGH ALL THREE BOXES QUICKLY BECAUSE THE NEEDLES POPPED OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925822 ↗
• MalfunctionFeb 20, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, IT WAS FOUND THAT THERE HAD BEEN A BLACK FOREIGN MATTER IN THE STERILE PACKAGE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. 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 24401205 ↗
• MalfunctionFeb 4, 2026Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THIS PRODUCT SUPPOSED THAT THERE WAS 1 NEEDLE, BUT IT WAS FOUND THAT THERE HAD BEEN 2 NEEDLES. (A SINGLE NEEDLE WAS MIXED IN.) THIS EVENT WAS FOUND BEFORE USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. 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 24261667 ↗
• MalfunctionSep 12, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, ACCORDING TO THIS STANDARD, IT WAS VISUALLY CONFIRMED THAT THE NEEDLE AT THE TIP WAS POINTING UPWARDS INSIDE THE PACKAGE AND HAD NOT PIERCED THE PACKAGING BUT HAD PIERCED THE PAPER WRAPPING INSIDE THE PACKAGE. THERE WERE NO NEEDLE STICKS OR OTHER IMPACTS DUE TO THIS EVENT. THIS EVENT WAS FOUND BEFORE USE. 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 23036829 ↗
• MalfunctionMay 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE WHEN THE DOCTOR WAS USING IT. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. 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. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22056610 ↗
• MalfunctionMay 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DISTRIBUTOR PER ACCOUNT THE NEEDLE COMPLETELY FELL OFF THE SUTURE AND ANOTHER SUTURE HAD TO BE USED. THIS DID NOT CAUSE ANY ISSUES FOR THE PATIENT BUT NEEDS TO BE SUBMITTED TO THEIR QUALITY CONTROL DEPARTMENT. UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22037267 ↗
• MalfunctionMar 26, 2025Delivered as Unsterile Product; Product Quality Problem; Delivered as Unsterile Product; Product Quality Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN THE PRODUCT WAS PICKED UP FROM THE STORAGE AREA BEFORE TAKING OUT TO THE OPERATING ROOM, IT WAS FOUND THAT THE NEEDLE WAS PROTRUDED FROM THE PACKAGE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO INJURIES OCCURRED TO HEALTHCARE PROFESSIONALS RELATED TO THIS PRODUCT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697439 ↗
• MalfunctionNov 12, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. A FOREIGN MATTER WAS FOUND. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664587 ↗

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-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-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-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.