ETHILON 585HRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705031006393), received between Aug 21, 2019 and Feb 21, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHILE SUTURING A DRAIN WITH THE SUTURE, THE TIP OF THE NEEDLE BROKE OFF AND COULD NOT BE LOCATED. BOX WITH SAME LOT NUMBER REMOVED FROM CIRCULATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21439376 ↗
• MalfunctionJan 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WHIPPLE PROCEDURE ON (B)(6) 2024 AND A SUTURE WAS USED. DURING THE PROCEDURE THE NEEDLE BROKE WHILE SUTURING UNKNOWN TISSUE. BROKEN FRAGMENT WAS NOT RECOVERED. AN X-RAY WAS NOT DONE. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21172794 ↗
• MalfunctionNov 22, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT SUTURES HAVE ALL BEEN DISINTEGRATING FOR OUR SURGEONS. THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20758000 ↗
• MalfunctionNov 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR FUSION SPINE PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE TRYING TO SUTURE, THE SUTURE WAS BREAKING INTO MULTIPLE PIECES AS THE SURGEON WAS TYING KNOTS. COMPLETED THE CASE BY USING AN ALTERNATE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20756605 ↗
• MalfunctionNov 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR FUSION SPINE PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE TRYING TO SUTURE, THE SUTURE WAS BREAKING INTO MULTIPLE PIECES AS THE SURGEON WAS TYING KNOTS. COMPLETED THE CASE BY USING AN ALTERNATE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20756595 ↗
• MalfunctionNov 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR FUSION SPINE PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE TRYING TO SUTURE, THE SUTURE WAS BREAKING INTO MULTIPLE PIECES AS THE SURGEON WAS TYING KNOTS. COMPLETED THE CASE BY USING AN ALTERNATE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20756590 ↗
• MalfunctionNov 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR FUSION SPINE PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE TRYING TO SUTURE, THE SUTURE WAS BREAKING INTO MULTIPLE PIECES AS THE SURGEON WAS TYING KNOTS. COMPLETED THE CASE BY USING AN ALTERNATE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20756584 ↗
• MalfunctionNov 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR FUSION SPINE PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE TRYING TO SUTURE, THE SUTURE WAS BREAKING INTO MULTIPLE PIECES AS THE SURGEON WAS TYING KNOTS. COMPLETED THE CASE BY USING AN ALTERNATE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20756582 ↗
• MalfunctionNov 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR FUSION SPINE PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE TRYING TO SUTURE, THE SUTURE WAS BREAKING INTO MULTIPLE PIECES AS THE SURGEON WAS TYING KNOTS. COMPLETED THE CASE BY USING AN ALTERNATE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20756581 ↗
• MalfunctionApr 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS EASILY DISCONNECTING WITH SUTURE STRAND. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773849 ↗
• MalfunctionDec 2, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE POPPED OFF THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12916047 ↗
• MalfunctionDec 2, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE POPPED OFF THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12916011 ↗
• MalfunctionDec 2, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE POPPED OFF THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12916006 ↗
• MalfunctionDec 2, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE POPPED OFF THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12915993 ↗
• MalfunctionDec 2, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE POPPED OFF THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12915977 ↗
• MalfunctionAug 21, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LESION EXCISION FROM THE LEFT LEG ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF NEEDLE BROKE OFF WHILE APPROXIMATING THE SKIN IN THE LEG. THE BROKEN NEEDLE TIP WAS RETRIEVED AND DISCARDED. ADDITIONAL SUTURE FROM THE SAME BOX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8915077 ↗
• MalfunctionAug 21, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LESION EXCISION FROM THE LEFT LEG ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF NEEDLE BROKE OFF WHILE APPROXIMATING THE SKIN IN THE LEG. THE BROKEN NEEDLE TIP WAS RETRIEVED AND DISCARDED. ADDITIONAL SUTURE FROM THE SAME BOX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8915073 ↗
• MalfunctionAug 21, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LESION EXCISION FROM THE LEFT LEG ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF NEEDLE BROKE OFF WHILE APPROXIMATING THE SKIN IN THE LEG. THE BROKEN NEEDLE TIP WAS RETRIEVED AND DISCARDED. ADDITIONAL SUTURE FROM THE SAME BOX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8915069 ↗

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.