ETHILON 1628HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031088054), received between May 1, 2025 and May 1, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. WE HAVE NOW EXPERIENCED WITH 4 PIECES FROM THIS BOX THAT THE NEEDLE IS SLIPPING FROM THE THREAD. NOW CHOOSING TO REMOVE IT FROM OUR SHELF. HAVE A NEW BOX, SAME TYPE WITH A DIFFERENT BATCH THAT WE NOW USE, HAVE NOT EXPERIENCED IT WITH THIS BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21945089 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. WE HAVE NOW EXPERIENCED WITH 4 PIECES FROM THIS BOX THAT THE NEEDLE IS SLIPPING FROM THE THREAD. NOW CHOOSING TO REMOVE IT FROM OUR SHELF. HAVE A NEW BOX, SAME TYPE WITH A DIFFERENT BATCH THAT WE NOW USE, HAVE NOT EXPERIENCED IT WITH THIS BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21945023 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. WE HAVE NOW EXPERIENCED WITH 4 PIECES FROM THIS BOX THAT THE NEEDLE IS SLIPPING FROM THE THREAD. NOW CHOOSING TO REMOVE IT FROM OUR SHELF. HAVE A NEW BOX, SAME TYPE WITH A DIFFERENT BATCH THAT WE NOW USE, HAVE NOT EXPERIENCED IT WITH THIS BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944976 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. WE HAVE NOW EXPERIENCED WITH 4 PIECES FROM THIS BOX THAT THE NEEDLE IS SLIPPING FROM THE THREAD. NOW CHOOSING TO REMOVE IT FROM OUR SHELF. HAVE A NEW BOX, SAME TYPE WITH A DIFFERENT BATCH THAT WE NOW USE, HAVE NOT EXPERIENCED IT WITH THIS BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944973 ↗

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.