ETHIBOND EXCEL X557HRecalls & reported problems

Summary

The FDA's MAUDE database contains 187 adverse event reports that list this exact device (DI 10705031057562), received between Apr 4, 2018 and Nov 14, 2025 — classified as 187 malfunctions.

The most frequently reported specific device problem is “Material Separation” (175 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 187 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED OVER THE COURSE OF 2 CASES THE RB1 NEEDLE WAS POPPING OFF THE SUTURE AND IT'S NOT A POP OFF SUTURE. THEY WOULDN'T USE ANYMORE SUTURE FROM THAT BOX. GOT ANOTHER BOX FROM ANOTHER HOSPITAL WITH A DIFFERENT LOT NUMBER TO USE FOR THE NEXT FEW WEEKS OF CASES. NO ADVERSE IMPACT TO THE PATIENT/USER. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23559970 ↗
• MalfunctionNov 14, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED OVER THE COURSE OF 2 CASES THE RB1 NEEDLE WAS POPPING OFF THE SUTURE AND IT'S NOT A POP OFF SUTURE. THEY WOULDN'T USE ANYMORE SUTURE FROM THAT BOX. GOT ANOTHER BOX FROM ANOTHER HOSPITAL WITH A DIFFERENT LOT NUMBER TO USE FOR THE NEXT FEW WEEKS OF CASES. NO ADVERSE IMPACT TO THE PATIENT/USER. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23559955 ↗
• MalfunctionNov 14, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED OVER THE COURSE OF 2 CASES THE RB1 NEEDLE WAS POPPING OFF THE SUTURE AND IT'S NOT A POP OFF SUTURE. THEY WOULDN'T USE ANYMORE SUTURE FROM THAT BOX. GOT ANOTHER BOX FROM ANOTHER HOSPITAL WITH A DIFFERENT LOT NUMBER TO USE FOR THE NEXT FEW WEEKS OF CASES. NO ADVERSE IMPACT TO THE PATIENT/USER. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23559946 ↗
• MalfunctionNov 14, 2025Material 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 THE SUTURE FRAYED. THERE IS NO ADVERSE IMPACT ON PATIENT/USER REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556949 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 5 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088564 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 5 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088395 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 5 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088388 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 5 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088321 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 5 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088302 ↗
• MalfunctionAug 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TENDON SUTURES PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. A TOTAL 3 PRODUCTS EXPERIENCED THE NEEDLE PULLING OFF ISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22776179 ↗
• MalfunctionAug 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TENDON SUTURES PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. A TOTAL 3 PRODUCTS EXPERIENCED THE NEEDLE PULLING OFF ISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22775349 ↗
• MalfunctionAug 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TENDON SUTURES PROCEDURE ON (B)(6) 2025 AND A SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. A TOTAL 3 PRODUCTS EXPERIENCED THE NEEDLE PULLING OFF ISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22775255 ↗
• MalfunctionAug 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TENDON SUTURES PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. A TOTAL 3 PRODUCTS EXPERIENCED THE NEEDLE PULLING OFF ISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22774929 ↗
• MalfunctionAug 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TENDON SUTURES PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. A TOTAL 3 PRODUCTS EXPERIENCED THE NEEDLE PULLING OFF ISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22774762 ↗
• MalfunctionAug 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TENDON SUTURES PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. A TOTAL 3 PRODUCTS EXPERIENCED THE NEEDLE PULLING OFF ISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22774604 ↗
• MalfunctionJan 30, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT MICROSCOPIC RESECTION OF BRAIN TUMORS PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE GOT SPLIT DURING THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608593 ↗
• MalfunctionOct 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISION OF BRAIN TUMORS SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE EXCISION OF BRAIN TUMORS SURGERY. CHANGED ANOTHER NINE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THE NEEDLE DID NOT FELL INTO THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18012980 ↗
• MalfunctionOct 24, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MICROSCOPIC RESECTION OF BRAIN TUMORS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER SEVEN TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THE NEEDLE DID NOT FELL INTO THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17998999 ↗
• MalfunctionOct 24, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MICROSCOPIC RESECTION OF BRAIN TUMORS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER SEVEN TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THE NEEDLE DID NOT FELL INTO THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17998998 ↗
• MalfunctionOct 24, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MICROSCOPIC RESECTION OF BRAIN TUMORS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER SEVEN TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THE NEEDLE DID NOT FELL INTO THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17998997 ↗
• MalfunctionOct 24, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MICROSCOPIC RESECTION OF BRAIN TUMORS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER SEVEN TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THE NEEDLE DID NOT FELL INTO THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17998992 ↗
• MalfunctionOct 24, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MICROSCOPIC RESECTION OF BRAIN TUMORS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER SEVEN TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THE NEEDLE DID NOT FELL INTO THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17998987 ↗
• MalfunctionOct 24, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MICROSCOPIC RESECTION OF BRAIN TUMORS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER SEVEN TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THE NEEDLE DID NOT FELL INTO THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17998984 ↗
• MalfunctionOct 24, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MICROSCOPIC RESECTION OF BRAIN TUMORS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER SEVEN TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THE NEEDLE DID NOT FELL INTO THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17998974 ↗
• MalfunctionOct 24, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MICROSCOPIC RESECTION OF BRAIN TUMORS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER SEVEN TO CONTINUE THE SURGERY, AND THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THE NEEDLE DID NOT FELL INTO THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17998971 ↗

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.