ETHILON 698HRecalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10705031008595), received between Sep 18, 2018 and May 29, 2026 — classified as 2 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Material Separation” (49 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 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THEY JUST SPOKE WITH THE DOCTOR'S OFFICE AND SHE SAID THEY ARE HAVING THESE 4-0 AND 5-0 SUTURE POP OFF THE NEEDLES WHEN THE DOCTOR IS TRYING TO TIE KNOTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333623 ↗
• MalfunctionMay 29, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THEY JUST SPOKE WITH THE DOCTOR'S OFFICE AND SHE SAID THEY ARE HAVING THESE 4-0 AND 5-0 SUTURE POP OFF THE NEEDLES WHEN THE DOCTOR IS TRYING TO TIE KNOTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333620 ↗
• MalfunctionMay 29, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THEY JUST SPOKE WITH THE DOCTOR'S OFFICE AND SHE SAID THEY ARE HAVING THESE 4-0 AND 5-0 SUTURE POP OFF THE NEEDLES WHEN THE DOCTOR IS TRYING TO TIE KNOTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333619 ↗
• MalfunctionMay 29, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THEY JUST SPOKE WITH THE DOCTOR'S OFFICE AND SHE SAID THEY ARE HAVING THESE 4-0 AND 5-0 SUTURE POP OFF THE NEEDLES WHEN THE DOCTOR IS TRYING TO TIE KNOTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333375 ↗
• MalfunctionMay 29, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THEY JUST SPOKE WITH THE DOCTOR'S OFFICE AND SHE SAID THEY ARE HAVING THESE 4-0 AND 5-0 SUTURE POP OFF THE NEEDLES WHEN THE DOCTOR IS TRYING TO TIE KNOTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333311 ↗
• MalfunctionMay 29, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THEY JUST SPOKE WITH THE DOCTOR'S OFFICE AND SHE SAID THEY ARE HAVING THESE 4-0 AND 5-0 SUTURE POP OFF THE NEEDLES WHEN THE DOCTOR IS TRYING TO TIE KNOTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333307 ↗
• MalfunctionMay 26, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE DOCTOR IS HAVING THESE SUTURES POP OFF THE NEEDLES WHEN THE DOCTOR IS TRYING TO TIE KNOTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280887 ↗
• MalfunctionMay 26, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE DOCTOR IS HAVING THESE SUTURES POP OFF THE NEEDLES WHEN THE DOCTOR IS TRYING TO TIE KNOTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279252 ↗
• MalfunctionMay 15, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE DOCTOR IS HAVING THESE SUTURES POP OFF THE NEEDLES WHEN THE DOCTOR IS TRYING TO TIE KNOTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25189651 ↗
• MalfunctionMay 15, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE DOCTOR IS HAVING THESE SUTURES POP OFF THE NEEDLES WHEN THE DOCTOR IS TRYING TO TIE KNOTS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25189645 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, DR.'S CLINIC PURCHASED 698H AND IN ONE CASE MULTIPLE SUTURES BROKE WHICH WAS A VERY HIGH NUMBER FOR ONE CASE. THIS WAS A TYPICAL CASE FOR THEM WHERE THERE WASN'T AN EXPLANATION FOR THE HIGH NUMBER OF BREAKAGES. THEY WERE ABLE TO COMPLETE THE CASE AND THERE WAS NO DELAY OR PATIENT OUTCOME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461512 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, DR.'S CLINIC PURCHASED 698H AND IN ONE CASE MULTIPLE SUTURES BROKE WHICH WAS A VERY HIGH NUMBER FOR ONE CASE. THIS WAS A TYPICAL CASE FOR THEM WHERE THERE WASN'T AN EXPLANATION FOR THE HIGH NUMBER OF BREAKAGES. THEY WERE ABLE TO COMPLETE THE CASE AND THERE WAS NO DELAY OR PATIENT OUTCOME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461507 ↗
• MalfunctionDec 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. THEY HAD AN ISSUE WITH THE SUTURE. THE NEEDLE EASILY POPS OFF. DOCTOR HAS BEEN USING THIS SUTURE FOR MANY YEARS AND JUST RECENTLY HAD THIS ISSUE. NUMEROUS SUTURE HAVE BEEN WASTED BECAUSE OF THE NEEDLE COMING OFF BEFORE THE SUTURE IS FULLY USED. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850834 ↗
• MalfunctionDec 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THEY HAD AN ISSUE WITH THE SUTURE. THE NEEDLE EASILY POPS OFF. DOCTOR HAS BEEN USING THIS SUTURE FOR MANY YEARS AND JUST RECENTLY HAD THIS ISSUE. NUMEROUS SUTURE HAVE BEEN WASTED BECAUSE OF THE NEEDLE COMING OFF BEFORE THE SUTURE IS FULLY USED. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850798 ↗
• MalfunctionDec 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THEY HAD AN ISSUE WITH THE SUTURE. THE NEEDLE EASILY POPS OFF. DOCTOR HAS BEEN USING THIS SUTURE FOR MANY YEARS AND JUST RECENTLY HAD THIS ISSUE. NUMEROUS SUTURE HAVE BEEN WASTED BECAUSE OF THE NEEDLE COMING OFF BEFORE THE SUTURE IS FULLY USED. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850765 ↗
• MalfunctionDec 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THEY HAD AN ISSUE WITH THE SUTURE. THE NEEDLE EASILY POPS OFF. DOCTOR HAS BEEN USING THIS SUTURE FOR MANY YEARS AND JUST RECENTLY HAD THIS ISSUE. NUMEROUS SUTURE HAVE BEEN WASTED BECAUSE OF THE NEEDLE COMING OFF BEFORE THE SUTURE IS FULLY USED. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850689 ↗
• MalfunctionDec 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THEY HAD AN ISSUE WITH THE SUTURE. THE NEEDLE EASILY POPS OFF. DOCTOR HAS BEEN USING THIS SUTURE FOR MANY YEARS AND JUST RECENTLY HAD THIS ISSUE. NUMEROUS SUTURE HAVE BEEN WASTED BECAUSE OF THE NEEDLE COMING OFF BEFORE THE SUTURE IS FULLY USED. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850680 ↗
• MalfunctionDec 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THEY HAD AN ISSUE WITH THE SUTURE. THE NEEDLE EASILY POPS OFF. DOCTOR HAS BEEN USING THIS SUTURE FOR MANY YEARS AND JUST RECENTLY HAD THIS ISSUE. NUMEROUS SUTURE HAVE BEEN WASTED BECAUSE OF THE NEEDLE COMING OFF BEFORE THE SUTURE IS FULLY USED. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850636 ↗
• MalfunctionDec 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THEY ORDERED SUTURE AND HAVE HAD AN ISSUE WITH THE SUTURE. THE NEEDLE EASILY POPS OFF. DOCTOR HAS BEEN USING THIS SUTURE FOR MANY YEARS AND JUST RECENTLY HAD THIS ISSUE. NUMEROUS SUTURE HAVE BEEN WASTED BECAUSE OF THE NEEDLE COMING OFF BEFORE THE SUTURE IS FULLY USED. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778536 ↗
• MalfunctionDec 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THEY ORDERED SUTURE AND HAVE HAD AN ISSUE WITH THE SUTURE. THE NEEDLE EASILY POPS OFF. DOCTOR HAS BEEN USING THIS SUTURE FOR MANY YEARS AND JUST RECENTLY HAD THIS ISSUE. NUMEROUS SUTURE HAVE BEEN WASTED BECAUSE OF THE NEEDLE COMING OFF BEFORE THE SUTURE IS FULLY USED. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778507 ↗
• MalfunctionDec 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THEY ORDERED SUTURE AND HAVE HAD AN ISSUE WITH THE SUTURE. THE NEEDLE EASILY POPS OFF. DOCTOR HAS BEEN USING THIS SUTURE FOR MANY YEARS AND JUST RECENTLY HAD THIS ISSUE. NUMEROUS SUTURE HAVE BEEN WASTED BECAUSE OF THE NEEDLE COMING OFF BEFORE THE SUTURE IS FULLY USED. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778503 ↗
• MalfunctionDec 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THEY ORDERED SUTURE AND HAVE HAD AN ISSUE WITH THE SUTURE. THE NEEDLE EASILY POPS OFF. DOCTOR HAS BEEN USING THIS SUTURE FOR MANY YEARS AND JUST RECENTLY HAD THIS ISSUE. NUMEROUS SUTURE HAVE BEEN WASTED BECAUSE OF THE NEEDLE COMING OFF BEFORE THE SUTURE IS FULLY USED. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778502 ↗
• MalfunctionNov 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE DOCTOR HAS REPORTED AN ISSUE WITH SUTURES. SPECIFICALLY, THE SUTURE IS DETACHING FROM THE BASE OF THE NEEDLE DURING USE, MAKING IT UNUSABLE. THEY HAD TO DISCARD APPROXIMATELY A DOZEN SUTURES DUE TO THIS DEFECT. DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631186 ↗
• MalfunctionNov 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE DOCTOR HAS REPORTED AN ISSUE WITH SUTURES. SPECIFICALLY, THE SUTURE IS DETACHING FROM THE BASE OF THE NEEDLE DURING USE, MAKING IT UNUSABLE. THEY HAD TO DISCARD APPROXIMATELY A DOZEN SUTURES DUE TO THIS DEFECT. DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617556 ↗
• MalfunctionNov 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE DOCTOR HAS REPORTED AN ISSUE WITH SUTURES. SPECIFICALLY, THE SUTURE IS DETACHING FROM THE BASE OF THE NEEDLE DURING USE, MAKING IT UNUSABLE. THEY HAD TO DISCARD APPROXIMATELY A DOZEN SUTURES DUE TO THIS DEFECT. DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617536 ↗

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.