ETHILON F2415HRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031238930), received between Sep 21, 2018 and May 5, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL (FEMALE DOG) UNDERWENT A MAMMECTOMY PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING SKIN SUTURE, AFTER TWO TISSUE PASSAGES AND WITHOUT EXERTING EXCESSIVE PRESSURE, THE NEEDLE BECAME DETACHED FROM THE THREAD. ANOTHER SUTURE FROM THE SAME BATCH WAS USED: THE NEEDLE PULLED OFF UNDER THE SAME CONDITIONS AFTER TWO OR THREE PASSES THROUGH THE SKIN. THE SURGERY COULD BE COMPLETED, USING A NEW THREAD, WITHOUT AFFECTING THE ANIMAL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962786 ↗
• MalfunctionMay 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL (FEMALE DOG) UNDERWENT A MAMMECTOMY PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING SKIN SUTURE, AFTER TWO TISSUE PASSAGES AND WITHOUT EXERTING EXCESSIVE PRESSURE, THE NEEDLE BECAME DETACHED FROM THE THREAD. ANOTHER SUTURE FROM THE SAME BATCH WAS USED: THE NEEDLE PULLED OFF UNDER THE SAME CONDITIONS AFTER TWO OR THREE PASSES THROUGH THE SKIN. THE SURGERY COULD BE COMPLETED, USING A NEW THREAD, WITHOUT AFFECTING THE ANIMAL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962777 ↗
• MalfunctionMar 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED WITH USE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634440 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP IT WAS OBSERVED PRESENCE OF MICRO-ABSCESS AT THE END OF THE THREAD. THE PATIENT HAD AN ABNORMAL REACTION. IT WAS REPORTED THAT FOR THE MOST PART, THE ISSUE REGRESSED AFTER REMOVAL OF THE THREAD, HOWEVER, THE PATIENT REQUIRED ANTIBIOTIC TREATMENT PRESCRIBED BY THE ATTENDING PHYSICIAN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Local Reaction

  MAUDE report 16809916 ↗
• MalfunctionAug 19, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT FOR THE PRODUCT CODE, THE EAN CODE PRESENTED ON THE PACKAGING IS NOT COMPLIANT WITH THE EUROPEAN MEDICAL DEVICE REGULATION. THE GTIN CODE ON THE PACKAGING IS INCORRECT. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10428261 ↗
• MalfunctionFeb 7, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A DOG UNDERWENT SUTURE OF A CUTANEOUS WOUND AT THE EAR AND SUTURE WAS USED. WHILE CLOSING OF CUTANEOUS WOUND OF THE AURICULAR PINNA, AFTER 4 TISSUE PASSAGES AND 2 SIMPLE STITCHES, THE NEEDLE PULLED OFF THE STRAND, WITHOUT ANY PARTICULAR FORCE APPLIED ON THE STRAND. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9683108 ↗
• MalfunctionSep 25, 2018Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLES FROM THE SAME BOX PULLED OFF. NO FURTHER INFORMATION AVAILABLE. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7906075 ↗
• MalfunctionSep 25, 2018Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLES FROM THE SAME BOX PULLED OFF. NO FURTHER INFORMATION AVAILABLE. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7906035 ↗
• MalfunctionSep 21, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANIMAL PROCEDURE WHEN PERFORMING THE CUTANEOUS SUTURE ON (B)(6) 2018 THE NEEDLE PULLED OFF THE SUTURE. NO ADVERSE PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7899329 ↗

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.