ETHILON 1865HRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031238626), received between Apr 4, 2024 and May 14, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Separation” (12 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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Material Separation; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE SIZE DIFFERENT FROM BEING SHOWN ON THE PACKING ALSO NEEDLE CAME OFF FROM SUTURE AFTER THE FIRST PASS IN TISSUE. THERE WERE NO SURGICAL DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171507 ↗
• MalfunctionMay 14, 2026Material Separation; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE SIZE DIFFERENT FROM BEING SHOWN ON THE PACKING ALSO NEEDLE CAME OFF FROM SUTURE AFTER THE FIRST PASS IN TISSUE. THERE WERE NO SURGICAL DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171097 ↗
• MalfunctionMay 14, 2026Material Separation; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE SIZE DIFFERENT FROM BEING SHOWN ON THE PACKING ALSO NEEDLE CAME OFF FROM SUTURE AFTER THE FIRST PASS IN TISSUE. THERE WERE NO SURGICAL DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25170904 ↗
• MalfunctionOct 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING PLASTIC SURGERY, THE SURGEON USED THE SUTURES AND COMPLAINED THAT EACH SUTURE GOT DISCONNECTED FROM THE NEEDLE. HE USED 7-8 SUTURES FROM THE SAME PACK, AND IT HAPPENED WITH EACH ONE. HE RECEIVED A NEW BOX OF THE SAME SUTURE AND THE SUTURES WERE FUNCTIONAL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311793 ↗
• MalfunctionOct 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING PLASTIC SURGERY, THE SURGEON USED THE SUTURES AND COMPLAINED THAT EACH SUTURE GOT DISCONNECTED FROM THE NEEDLE. HE USED 7-8 SUTURES FROM THE SAME PACK, AND IT HAPPENED WITH EACH ONE. HE RECEIVED A NEW BOX OF THE SAME SUTURE AND THE SUTURES WERE FUNCTIONAL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311790 ↗
• MalfunctionOct 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING PLASTIC SURGERY, THE SURGEON USED THE SUTURES AND COMPLAINED THAT EACH SUTURE GOT DISCONNECTED FROM THE NEEDLE. HE USED 7-8 SUTURES FROM THE SAME PACK, AND IT HAPPENED WITH EACH ONE. HE RECEIVED A NEW BOX OF THE SAME SUTURE AND THE SUTURES WERE FUNCTIONAL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311784 ↗
• MalfunctionOct 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING PLASTIC SURGERY, THE SURGEON USED THE SUTURES AND COMPLAINED THAT EACH SUTURE GOT DISCONNECTED FROM THE NEEDLE. HE USED 7-8 SUTURES FROM THE SAME PACK, AND IT HAPPENED WITH EACH ONE. HE RECEIVED A NEW BOX OF THE SAME SUTURE AND THE SUTURES WERE FUNCTIONAL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311782 ↗
• MalfunctionOct 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING PLASTIC SURGERY, THE SURGEON USED THE SUTURES AND COMPLAINED THAT EACH SUTURE GOT DISCONNECTED FROM THE NEEDLE. HE USED 7-8 SUTURES FROM THE SAME PACK, AND IT HAPPENED WITH EACH ONE. HE RECEIVED A NEW BOX OF THE SAME SUTURE AND THE SUTURES WERE FUNCTIONAL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311778 ↗
• MalfunctionOct 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING PLASTIC SURGERY, THE SURGEON USED THE SUTURES AND COMPLAINED THAT EACH SUTURE GOT DISCONNECTED FROM THE NEEDLE. HE USED 7-8 SUTURES FROM THE SAME PACK, AND IT HAPPENED WITH EACH ONE. HE RECEIVED A NEW BOX OF THE SAME SUTURE AND THE SUTURES WERE FUNCTIONAL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311777 ↗
• MalfunctionOct 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING PLASTIC SURGERY, THE SURGEON USED THE SUTURES AND COMPLAINED THAT EACH SUTURE GOT DISCONNECTED FROM THE NEEDLE. HE USED 7-8 SUTURES FROM THE SAME PACK, AND IT HAPPENED WITH EACH ONE. HE RECEIVED A NEW BOX OF THE SAME SUTURE AND THE SUTURES WERE FUNCTIONAL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311776 ↗
• MalfunctionOct 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING PLASTIC SURGERY, THE SURGEON USED THE SUTURES AND COMPLAINED THAT EACH SUTURE GOT DISCONNECTED FROM THE NEEDLE. HE USED 7-8 SUTURES FROM THE SAME PACK, AND IT HAPPENED WITH EACH ONE. HE RECEIVED A NEW BOX OF THE SAME SUTURE AND THE SUTURES WERE FUNCTIONAL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311774 ↗
• MalfunctionOct 1, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS STICKING OUT OF THE PACKAGING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23194164 ↗
• MalfunctionJun 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT A HAND SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. THE NEEDLE DETACHED FROM THE THREAD WHEN SUTURING. NEW SUTURE FROM A DIFFERENT LOT WAS USED INSTEAD. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528742 ↗
• MalfunctionApr 4, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. PREOPERATIVELY, THE NEEDLE TIP WAS MISSING. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19041667 ↗

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.