ETHILON 662GRecalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10705031007734), received between Feb 9, 2018 and Nov 25, 2025 — classified as 1 injury, 37 malfunctions.

The most frequently reported specific device problem is “Break” (28 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Break; Break

  IT WAS REPORTED BY A SALES REP THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN IN THE CASE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647022 ↗
• MalfunctionNov 25, 2025Break; Break

  IT WAS REPORTED BY A SALES REP THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN IN THE CASE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647021 ↗
• MalfunctionNov 25, 2025Break; Break

  IT WAS REPORTED BY A SALES REP THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN IN THE CASE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647012 ↗
• MalfunctionNov 25, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN USING THE PRODUCT, THE SUTURE WAS BROKEN 3 TIMES IN A ROW. IT IS UNCLEAR WHETHER THIS IS ONE CASE, AND IT IS CURRENTLY CONFIRMING IN WHAT CIRCUMSTANCES THE SUTURE WAS BROKEN 3 TIMES IN A ROW. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646577 ↗
• MalfunctionNov 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, DISTRIBUTOR HAS BEEN ADVISED BY THE CLINIC THAT SUTURE 662V LOT 1062DH APPEARS TO BE DEFECTIVE. THE SUTURE WAS BREAKING AND SNAPPING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584532 ↗
• MalfunctionMay 16, 2025Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN SKIN CLOSURE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED AS THE SURGEON WAS USING THE SUTURES HE NOTICED THAT THE SUTURES BEGAN TO CHANGE COLOR AND APPEARED TO DEGRADE OR BREAK MORE EASILY THAN EXPECTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22037473 ↗
• MalfunctionMay 16, 2025Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN SKIN CLOSURE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED AS THE SURGEON WAS USING THE SUTURES HE NOTICED THAT THE SUTURES BEGAN TO CHANGE COLOR AND APPEARED TO DEGRADE OR BREAK MORE EASILY THAN EXPECTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22037460 ↗
• MalfunctionMay 13, 2025Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN SKIN CLOSURE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED AS THE SURGEON WAS USING THE SUTURES HE NOTICED THAT THE SUTURES BEGAN TO CHANGE COLOR AND APPEARED TO DEGRADE OR BREAK MORE EASILY THAN EXPECTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011789 ↗
• MalfunctionMay 13, 2025Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN SKIN CLOSURE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED AS THE SURGEON WAS USING THE SUTURES HE NOTICED THAT THE SUTURES BEGAN TO CHANGE COLOR AND APPEARED TO DEGRADE OR BREAK MORE EASILY THAN EXPECTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011779 ↗
• MalfunctionMay 13, 2025Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN SKIN CLOSURE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED AS THE SURGEON WAS USING THE SUTURES HE NOTICED THAT THE SUTURES BEGAN TO CHANGE COLOR AND APPEARED TO DEGRADE OR BREAK MORE EASILY THAN EXPECTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011778 ↗
• MalfunctionMay 13, 2025Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN SKIN CLOSURE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED AS THE SURGEON WAS USING THE SUTURES HE NOTICED THAT THE SUTURES BEGAN TO CHANGE COLOR AND APPEARED TO DEGRADE OR BREAK MORE EASILY THAN EXPECTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011776 ↗
• MalfunctionMay 13, 2025Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN SKIN CLOSURE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED AS THE SURGEON WAS USING THE SUTURES HE NOTICED THAT THE SUTURES BEGAN TO CHANGE COLOR AND APPEARED TO DEGRADE OR BREAK MORE EASILY THAN EXPECTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011775 ↗
• MalfunctionMay 13, 2025Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN SKIN CLOSURE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED AS THE SURGEON WAS USING THE SUTURES HE NOTICED THAT THE SUTURES BEGAN TO CHANGE COLOR AND APPEARED TO DEGRADE OR BREAK MORE EASILY THAN EXPECTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011750 ↗
• MalfunctionMay 13, 2025Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN SKIN CLOSURE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED AS THE SURGEON WAS USING THE SUTURES HE NOTICED THAT THE SUTURES BEGAN TO CHANGE COLOR AND APPEARED TO DEGRADE OR BREAK MORE EASILY THAN EXPECTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011748 ↗
• MalfunctionMay 13, 2025Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN SKIN CLOSURE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED AS THE SURGEON WAS USING THE SUTURES HE NOTICED THAT THE SUTURES BEGAN TO CHANGE COLOR AND APPEARED TO DEGRADE OR BREAK MORE EASILY THAN EXPECTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011747 ↗
• MalfunctionMay 13, 2025Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN SKIN CLOSURE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED AS THE SURGEON WAS USING THE SUTURES HE NOTICED THAT THE SUTURES BEGAN TO CHANGE COLOR AND APPEARED TO DEGRADE OR BREAK MORE EASILY THAN EXPECTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011701 ↗
• MalfunctionMay 13, 2025Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN SKIN CLOSURE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED AS THE SURGEON WAS USING THE SUTURES HE NOTICED THAT THE SUTURES BEGAN TO CHANGE COLOR AND APPEARED TO DEGRADE OR BREAK MORE EASILY THAN EXPECTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011694 ↗
• MalfunctionOct 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE NYLON POPPED OFF OF THE NEEDLE WHEN THE PROVIDER WAS SUTURING. THIS WAS A MALFUNCTION FOR THIS SUTURE. DEVICE AVAILABILITY UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20534434 ↗
• MalfunctionOct 8, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT SEVERAL PACKETS WERE OPENED AS THE SUTURE MATERIAL KEPT SNAPPING/BREAKING WITHOUT MUCH FORCE. ANOTHER SUTURE WAS FOUND WITH A DIFFERENT LOT NUMBER AND WORKED PERFECTLY STAYING STRONG. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20398683 ↗
• MalfunctionOct 8, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. IT WAS REPORTED THAT SEVERAL PACKETS WERE OPENED AS THE SUTURE MATERIAL KEPT SNAPPING/BREAKING WITHOUT MUCH FORCE. ANOTHER SUTURE WAS FOUND WITH A DIFFERENT LOT NUMBER AND WORKED PERFECTLY STAYING STRONG. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20398671 ↗
• MalfunctionJul 15, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER IS REPORTING THAT THEY RECEIVED A DAMAGED BOXES AND WHEN THEY WENT TO USE SUTURE THAT IT WAS FALLING APART BEFORE ANY PRESSURE WOULD BE APPLIED TO THEM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19746730 ↗
• MalfunctionJul 15, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER IS REPORTING THAT THEY RECEIVED A DAMAGED BOXES AND WHEN THEY WENT TO USE SUTURE THAT IT WAS FALLING APART BEFORE ANY PRESSURE WOULD BE APPLIED TO THEM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19746726 ↗
• MalfunctionFeb 27, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE DURING INTERRUPTED SUTURE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18791572 ↗
• MalfunctionFeb 27, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE DURING INTERRUPTED SUTURE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18791571 ↗
• MalfunctionMay 26, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THERE WAS A FOREIGN SUBSTANCE WHICH WAS DERIVED FROM EITHER HUMAN HAIR OR INSECT OR OTHER LIVING ORGANISM IN THE STERILE PACKAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010893 ↗

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.