ETHILON 664HRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10705031007826), received between Aug 7, 2018 and Mar 3, 2026 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. WHEN THE SURGEONS USED THE DRAIN STITCH, THEY PULLED OFF THE SWEDGED ON SUTURE AND THE NEEDLE BROKE. BOTH PIECES WERE LOCATED AND DISCARDED AT END OF PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497441 ↗
• MalfunctionNov 25, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE BROKE. THERE WERE NO PATIENT ADVERSE EVENT AND NO CASE DELAY. PRODUCT IS NOT FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647287 ↗
• MalfunctionApr 19, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL BRACHIOPLASTY, BILATERAL MASTOPEXY, BILATERAL BREAST AUGMENTATION WITH SILICONE IMPLANT ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE; WHILE USING A NYLON SUTURE, SURGEON NOTED DAMAGE TO SUTURE NEEDLE. BROKEN PART OBSERVED BY SURGEON AND RNFA TO FALL ON PATIENT SKIN. BOTH PIECES EXAMINED BY SURGICAL TEAM AND PASSED OFF THE FIELD FOR LATER REVIEW. X-RAY WAS REQUESTED TO RULE OUT POTENTIAL RETAINED PORTION. X-RAY WAS NEGATIVE, NO RETAINED SUTURE, CLOSURE RESUMED. SUTURE NEEDLE AND PACKAGING SAVED FOR LATER REVIEW. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143088 ↗
• MalfunctionOct 25, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BECAME DETACHED FROM THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18008433 ↗
• MalfunctionOct 25, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BECAME DETACHED FROM THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18008432 ↗
• MalfunctionMar 23, 2023Break; Packaging Problem; Break; Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT EXCISION OF MULTIPLE SKIN LESIONS ON (B)(6) 2023 AND SUTURE WAS USED. THE WHOLE LOT WAS VERY FRAGILE, THE WRAPPER WOULD EASILY TEAR AND DETERIORATE WHEN OPENING. THE PLASTIC HOLDER/CASE WOULD EASILY CRACK WITH LITTLE FORCE AND THE SUTURE STRING ITSELF WAS BREAKING WHILE THE SURGEON WAS USING IT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16599845 ↗
• MalfunctionFeb 28, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A FOREIGN BODY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POSTOPERATIVELY, THE SUTURES WERE SEVENTY PERCENT UNSECURED. THE KNOTS UNTIED POST OPERATIVELY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Wound Dehiscence

  MAUDE report 16457087 ↗
• MalfunctionFeb 28, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A FOREIGN BODY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POSTOPERATIVELY, THE SUTURES WERE SEVENTY PERCENT UNSECURED. THE KNOTS UNTIED POST OPERATIVELY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Wound Dehiscence

  MAUDE report 16456562 ↗
• MalfunctionFeb 28, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A FOREIGN BODY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POSTOPERATIVELY, THE SUTURES WERE SEVENTY PERCENT UNSECURED. THE KNOTS UNTIED POST OPERATIVELY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Wound Dehiscence

  MAUDE report 16456062 ↗
• MalfunctionFeb 28, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A FOREIGN BODY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POSTOPERATIVELY, THE SUTURES WERE SEVENTY PERCENT UNSECURED. THE KNOTS UNTIED POST OPERATIVELY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Wound Dehiscence

  MAUDE report 16455796 ↗
• MalfunctionFeb 28, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A FOREIGN BODY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POSTOPERATIVELY, THE SUTURES WERE SEVENTY PERCENT UNSECURED. THE KNOTS UNTIED POST OPERATIVELY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Wound Dehiscence

  MAUDE report 16455724 ↗
• MalfunctionFeb 28, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A FOREIGN BODY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POSTOPERATIVELY, THE SUTURES WERE SEVENTY PERCENT UNSECURED. THE KNOTS UNTIED POST OPERATIVELY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Wound Dehiscence

  MAUDE report 16455721 ↗
• MalfunctionFeb 28, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A FOREIGN BODY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POSTOPERATIVELY, THE SUTURES WERE SEVENTY PERCENT UNSECURED. THE KNOTS UNTIED POST OPERATIVELY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Wound Dehiscence

  MAUDE report 16455713 ↗
• MalfunctionFeb 28, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A FOREIGN BODY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POSTOPERATIVELY, THE SUTURES WERE SEVENTY PERCENT UNSECURED. THE KNOTS UNTIED POST OPERATIVELY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Wound Dehiscence

  MAUDE report 16455712 ↗
• MalfunctionFeb 28, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A FOREIGN BODY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POSTOPERATIVELY, THE SUTURES WERE SEVENTY PERCENT UNSECURED. THE KNOTS UNTIED POST OPERATIVELY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Wound Dehiscence

  MAUDE report 16455709 ↗
• MalfunctionFeb 21, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN ANIMAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT POST OP TO ANIMAL SURGERY SEVEN OF TWELVE PATIENTS RETURNED, BECAUSE THE SUTURES WERE UNRAVELLING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16408830 ↗
• MalfunctionFeb 21, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN ANIMAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT POST OP TO ANIMAL SURGERY SEVEN OF TWELVE PATIENTS RETURNED, BECAUSE THE SUTURES WERE UNRAVELLING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16408796 ↗
• MalfunctionFeb 21, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN ANIMAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT POST OP TO ANIMAL SURGERY SEVEN OF TWELVE PATIENTS RETURNED, BECAUSE THE SUTURES WERE UNRAVELLING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16408785 ↗
• MalfunctionFeb 21, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN ANIMAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT POST OP TO ANIMAL SURGERY SEVEN OF TWELVE PATIENTS RETURNED BECAUSE THE SUTURES WERE UNRAVELLING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16408772 ↗
• MalfunctionFeb 21, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN ANIMAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT POST OP TO ANIMAL SURGERY SEVEN OF TWELVE PATIENTS RETURNED, BECAUSE THE SUTURES WERE UNRAVELLING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16408763 ↗
• MalfunctionFeb 21, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN ANIMAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT POST OP TO ANIMAL SURGERY SEVEN OF TWELVE PATIENTS RETURNED BECAUSE THE SUTURES WERE UNRAVELLING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16408755 ↗
• MalfunctionFeb 21, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN ANIMAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT POST OP TO ANIMAL SURGERY SEVEN OF TWELVE PATIENTS RETURNED BECAUSE THE SUTURES WERE UNRAVELLING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16408742 ↗
• MalfunctionJun 15, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT A MISMATCH OF RFID TAG. THE CODE 664H HAD THE TAG OF CODE EL5ML WAS NOTED ON THE PACKAGING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14696214 ↗
• MalfunctionMay 10, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY PROCEDURE IN (B)(6)2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE TIP BROKE OFF SUTURE & WAS RETRIEVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14346469 ↗
• MalfunctionSep 29, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RE-DO LEFT CRANIOTOMY PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS CATCHING ON ITSELF, STICKING THE ENTIRE WAY. THE SUTURE WAS PULLED HARD TO GET THE KNOT DOWN AND THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12546392 ↗

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.