ETHILON 1855GRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10705031002777), received between Apr 25, 2023 and Dec 23, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Material Separation” (21 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Material Separation; Material Separation

  WHEN USING THE SUTURE 1855G, [REDACTED] HAD TO USE 8 SUTURES TO FINISH A SURGERY WHEN USUALLY DR. USES 1. THE NEEDLES DETACHED EASILY FROM THE SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879393 ↗
• MalfunctionDec 23, 2025Material Separation; Material Separation

  WHEN USING THE SUTURE 1855G, [REDACTED] HAD TO USE 8 SUTURES TO FINISH A SURGERY WHEN USUALLY DR. USES 1. THE NEEDLES DETACHED EASILY FROM THE SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879392 ↗
• MalfunctionDec 23, 2025Material Separation; Material Separation

  WHEN USING THE SUTURE 1855G, [REDACTED] HAD TO USE 8 SUTURES TO FINISH A SURGERY WHEN USUALLY DR. USES 1. THE NEEDLES DETACHED EASILY FROM THE SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879379 ↗
• MalfunctionDec 23, 2025Material Separation; Material Separation

  WHEN USING THE SUTURE 1855G, [REDACTED] HAD TO USE 8 SUTURES TO FINISH A SURGERY WHEN USUALLY DR. USES 1. THE NEEDLES DETACHED EASILY FROM THE SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879376 ↗
• MalfunctionDec 23, 2025Material Separation; Material Separation

  WHEN USING THE SUTURE 1855G, [REDACTED] HAD TO USE 8 SUTURES TO FINISH A SURGERY WHEN USUALLY DR. USES 1. THE NEEDLES DETACHED EASILY FROM THE SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879371 ↗
• MalfunctionDec 23, 2025Material Separation; Material Separation

  WHEN USING THE SUTURE 1855G, [REDACTED] HAD TO USE 8 SUTURES TO FINISH A SURGERY WHEN USUALLY DR. USES 1. THE NEEDLES DETACHED EASILY FROM THE SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879368 ↗
• MalfunctionDec 23, 2025Material Separation; Material Separation

  WHEN USING THE SUTURE 1855G, [REDACTED] HAD TO USE 8 SUTURES TO FINISH A SURGERY WHEN USUALLY DR. USES 1. THE NEEDLES DETACHED EASILY FROM THE SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879366 ↗
• MalfunctionDec 23, 2025Material Separation; Material Separation

  WHEN USING THE SUTURE 1855G, [REDACTED] HAD TO USE 8 SUTURES TO FINISH A SURGERY WHEN USUALLY DR. USES 1. THE NEEDLES DETACHED EASILY FROM THE SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879352 ↗
• MalfunctionMay 30, 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 BY THE DISTRIBUTOR THAT THE COSTUMER USING 5-0 NYLON AND THE NEEDLE KEEPS POPPING OFF. IT HAPPENED TO THE MULTIPLE DOCTORS AND JUST BEING CONNECTED THAT THEY ARE ALL HAVE THE SAME LOT NUMBER. UNKNOWN NUMBER OF DEVICES AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22117183 ↗
• MalfunctionMay 30, 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 BY THE DISTRIBUTOR THAT THE COSTUMER USING 5-0 NYLON AND THE NEEDLE KEEPS POPPING OFF. IT HAPPENED TO THE MULTIPLE DOCTORS AND JUST BEING CONNECTED THAT THEY ARE ALL HAVE THE SAME LOT NUMBER. UNKNOWN NUMBER OF DEVICES AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22117181 ↗
• MalfunctionMay 30, 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 BY THE DISTRIBUTOR THAT THE COSTUMER USING 5-0 NYLON AND THE NEEDLE KEEPS POPPING OFF. IT HAPPENED TO THE MULTIPLE DOCTORS AND JUST BEING CONNECTED THAT THEY ARE ALL HAVE THE SAME LOT NUMBER. UNKNOWN NUMBER OF DEVICES AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22117180 ↗
• MalfunctionMay 30, 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 BY THE DISTRIBUTOR THAT THE COSTUMER USING 5-0 NYLON AND THE NEEDLE KEEPS POPPING OFF. IT HAPPENED TO THE MULTIPLE DOCTORS AND JUST BEING CONNECTED THAT THEY ARE ALL HAVE THE SAME LOT NUMBER. UNKNOWN NUMBER OF DEVICES AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22117171 ↗
• MalfunctionMay 30, 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 BY THE DISTRIBUTOR THAT THE COSTUMER USING 5-0 NYLON AND THE NEEDLE KEEPS POPPING OFF. IT HAPPENED TO THE MULTIPLE DOCTORS AND JUST BEING CONNECTED THAT THEY ARE ALL HAVE THE SAME LOT NUMBER. UNKNOWN NUMBER OF DEVICES AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116933 ↗
• MalfunctionMay 30, 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 BY THE DISTRIBUTOR THAT THE COSTUMER USING 5-0 NYLON AND THE NEEDLE KEEPS POPPING OFF. IT HAPPENED TO THE MULTIPLE DOCTORS AND JUST BEING CONNECTED THAT THEY ARE ALL HAVE THE SAME LOT NUMBER. UNKNOWN NUMBER OF DEVICES AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116932 ↗
• MalfunctionMay 30, 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 BY THE DISTRIBUTOR THAT THE COSTUMER USING 5-0 NYLON AND THE NEEDLE KEEPS POPPING OFF. IT HAPPENED TO THE MULTIPLE DOCTORS AND JUST BEING CONNECTED THAT THEY ARE ALL HAVE THE SAME LOT NUMBER. UNKNOWN NUMBER OF DEVICES AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116931 ↗
• MalfunctionMay 30, 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 BY THE DISTRIBUTOR THAT THE COSTUMER USING 5-0 NYLON AND THE NEEDLE KEEPS POPPING OFF. IT HAPPENED TO THE MULTIPLE DOCTORS AND JUST BEING CONNECTED THAT THEY ARE ALL HAVE THE SAME LOT NUMBER. UNKNOWN NUMBER OF DEVICES AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116930 ↗
• MalfunctionMay 30, 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 BY THE DISTRIBUTOR THAT THE COSTUMER USING 5-0 NYLON AND THE NEEDLE KEEPS POPPING OFF. IT HAPPENED TO THE MULTIPLE DOCTORS AND JUST BEING CONNECTED THAT THEY ARE ALL HAVE THE SAME LOT NUMBER. UNKNOWN NUMBER OF DEVICES AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116929 ↗
• MalfunctionFeb 26, 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 THE DISTRIBUTOR THAT THE SUTURE KEEP COMING OFF THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471553 ↗
• MalfunctionApr 25, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE MATERIAL CAME LOOSE FROM THE NEEDLE IN 3 SEPARATE TIMES. UNABLE TO FIND SUTURE NEEDLE FROM INITIALLY INCIDENT. VERIFIED SUTURE WAS NOT IN THE PATIENT SO NO FOLLOW UP IMAGING WAS NEEDED. PATIENT WAS INFORMED THAT THE SUTURE WAS MISSING IN CASE IT HAD ATTACHED TO PATIENTS CLOTHING THAT WE COULDN'T SEE. SUTURE WAS NEVER IN THE PATIENT SO NO BBE WOULD BE NEEDED IF SUTURE IS FOUND. CLEANED AND SEARCHED ENTIRE ROOM WITH NO LUCK OF FINDING SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811674 ↗
• MalfunctionApr 25, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE MATERIAL CAME LOOSE FROM THE NEEDLE IN 3 SEPARATE TIMES. UNABLE TO FIND SUTURE NEEDLE FROM INITIALLY INCIDENT. VERIFIED SUTURE WAS NOT IN THE PATIENT SO NO FOLLOW UP IMAGING WAS NEEDED. PATIENT WAS INFORMED THAT THE SUTURE WAS MISSING IN CASE IT HAD ATTACHED TO PATIENTS CLOTHING THAT WE COULDN'T SEE. SUTURE WAS NEVER IN THE PATIENT SO NO BBE WOULD BE NEEDED IF SUTURE IS FOUND. CLEANED AND SEARCHED ENTIRE ROOM WITH NO LUCK OF FINDING SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811673 ↗
• MalfunctionApr 25, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE MATERIAL CAME LOOSE FROM THE NEEDLE IN 3 SEPARATE TIMES. UNABLE TO FIND SUTURE NEEDLE FROM INITIALLY INCIDENT. VERIFIED SUTURE WAS NOT IN THE PATIENT SO NO FOLLOW UP IMAGING WAS NEEDED. PATIENT WAS INFORMED THAT THE SUTURE WAS MISSING IN CASE IT HAD ATTACHED TO PATIENTS CLOTHING THAT WE COULDN'T SEE. SUTURE WAS NEVER IN THE PATIENT SO NO BBE WOULD BE NEEDED IF SUTURE IS FOUND. CLEANED AND SEARCHED ENTIRE ROOM WITH NO LUCK OF FINDING SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811672 ↗

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.