ETHILON F2417HRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031238954), received between Jun 19, 2019 and Sep 28, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 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.

• MalfunctionSep 28, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923482 ↗
• MalfunctionJan 5, 2026Break; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DEVICES BROKE EASILY. THEY ARE FRAGILE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23961782 ↗
• MalfunctionNov 4, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE EASILY DETACHED FROM THE SUTURE. THEY TOOK ITEMS OUT OF ANOTHER BOX OF THE SAME LOT AND HAD THE SAME ISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15739254 ↗
• MalfunctionNov 4, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE EASILY DETACHED FROM THE SUTURE. THEY TOOK ITEMS OUT OF ANOTHER BOX OF THE SAME LOT AND HAD THE SAME ISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15738111 ↗
• MalfunctionSep 6, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366674 ↗
• MalfunctionSep 6, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366672 ↗
• MalfunctionSep 6, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366667 ↗
• MalfunctionApr 11, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A LAPAROTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE ¿GENTLE¿ CLEANING OF THE CUTANEOUS WOUND (PASSAGE OF A COMPRESS TO REMOVE THE BLOOD) IN THE IMMEDIATE POSTOPERATIVE PERIOD, THE SUTURE BROKE IN THE LENGTH OF THE OVERJET. THE KNOT REMAINED INTACT. THE WOUND WAS REVISED USING ANOTHER SUTURE OF THE SAME PRODUCT CODE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14074070 ↗
• MalfunctionApr 11, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A LAPAROTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE ¿GENTLE¿ CLEANING OF THE CUTANEOUS WOUND (PASSAGE OF A COMPRESS TO REMOVE THE BLOOD) IN THE IMMEDIATE POSTOPERATIVE PERIOD, THE SUTURE BROKE IN THE LENGTH OF THE OVERJET. THE KNOT REMAINED INTACT. THE WOUND WAS REVISED USING ANOTHER SUTURE OF THE SAME PRODUCT CODE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14073997 ↗
• MalfunctionApr 11, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN MAMMECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE RUPTURED, IN THE LENGTH OF THE OVERJET, OCCURRED TWO DAYS AFTER THE SURGERY. CUTANEOUS STAPLES WERE PLACED TO CLOSE THE WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14073960 ↗
• MalfunctionMar 19, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF FROM THE THREAD, WITHOUT EXERTING EXCESSIVE TENSION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY INCIDENT ON THE ANIMAL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13826754 ↗
• MalfunctionSep 18, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE EASILY DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9081162 ↗
• MalfunctionJun 19, 2019Material Separation; Material Separation

  IT WAS REPORTED BY A VETERINARIAN THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PULLED OFF FROM THE THREAD AFTER A FEW TISSUE PASSAGES, WITHOUT EXERTING EXCESSIVE TENSION ON THE THREAD. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8712452 ↗
• MalfunctionJun 19, 2019Material Separation; Material Separation

  IT WAS REPORTED BY A VETERINARIAN THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE PULLED OFF FROM THE THREAD AFTER A FEW TISSUE PASSAGES, WITHOUT EXERTING EXCESSIVE TENSION ON THE THREAD. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8712451 ↗

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.