ETHIBOND EXCEL X872HRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705031058187), received between Nov 19, 2018 and Oct 15, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Dec 20, 2024Class IIOpen, Classified

   Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

   Z-1097-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, FOLLOWING ONGOING ISSUES WITH THE SAME CODE AND BATCH OF 3-0 ETHIBOND SUTURES, A PACKET WAS OPENED BY THE SURGEON. UPON IDENTIFYING IT AS PART OF THE PROBLEMATIC BATCH, THE SURGEON TESTED ITS TENSILE STRENGTH BY APPLYING MANUAL TENSION. THE SUTURE BROKE MID-STRAND WITH MINIMAL EFFORT, INDICATING IT FAILED UNDER NORMAL HANDLING CONDITIONS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279784 ↗
• MalfunctionSep 11, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WILL ATTEMPT TO OBTAIN SAMPLES. THE SURGEON USED IT AND AGAIN EASILY BROKE WHEN BEING KNOTTED. ADDITIONAL INFORMATION HAVE BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23028616 ↗
• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UROLOGY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, I AM WRITING THIS EMAIL TO GIVE SOME FEEDBACK SHARED BY OUR UROLOGY SURGEONS REGARDING THE ETHIBOND 3-0. WE HAVE DONE PENILE PLICATION PROCEDURES RECENTLY, AND FOR THE PAST TWO OCCASIONS, THE 3-0 ETHIBOND RB-1 HAS BEEN BREAKING WHEN THEY ARE TYING A KNOT. WHILE A 3-0 ETHIBOND IS QUITE A SMALL SUTURE, THE SURGEONS BELIEVE IT SHOULD NOT BE BREAKABLE BY THEIR HANDS WHEN TYING A KNOT. WE OPENED TWO SUTURES TODAY, THE 3-0 ETHIBOND ON RB1 REF NO: (B)(4), LOT: SJBDSZ, AND 3-0 ETHIBOND SH REF NO. (B)(4), LOT: TLBEQR, AND WE WERE ABLE TO BREAK IT WITH MEDIUM EFFORT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22556304 ↗
• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UROLOGY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, I AM WRITING THIS EMAIL TO GIVE SOME FEEDBACK SHARED BY OUR UROLOGY SURGEONS REGARDING THE ETHIBOND 3-0. WE HAVE DONE PENILE PLICATION PROCEDURES RECENTLY, AND FOR THE PAST TWO OCCASIONS, THE 3-0 ETHIBOND RB-1 HAS BEEN BREAKING WHEN THEY ARE TYING A KNOT. WHILE A 3-0 ETHIBOND IS QUITE A SMALL SUTURE, THE SURGEONS BELIEVE IT SHOULD NOT BE BREAKABLE BY THEIR HANDS WHEN TYING A KNOT. WE OPENED TWO SUTURES TODAY, THE 3-0 ETHIBOND ON RB1 REF NO: X872, LOT: SJBDSZ, AND 3-0 ETHIBOND SH REF NO. X832, LOT: TLBEQR, AND WE WERE ABLE TO BREAK IT WITH MEDIUM EFFORT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22556061 ↗
• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UROLOGY PROCEDURE (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, I AM WRITING THIS EMAIL TO GIVE SOME FEEDBACK SHARED BY OUR UROLOGY SURGEONS REGARDING THE ETHIBOND 3-0. WE HAVE DONE PENILE PLICATION PROCEDURES RECENTLY, AND FOR THE PAST TWO OCCASIONS, THE 3-0 ETHIBOND RB-1 HAS BEEN BREAKING WHEN THEY ARE TYING A KNOT. WHILE A 3-0 ETHIBOND IS QUITE A SMALL SUTURE, THE SURGEONS BELIEVE IT SHOULD NOT BE BREAKABLE BY THEIR HANDS WHEN TYING A KNOT. WE OPENED TWO SUTURES TODAY, THE 3-0 ETHIBOND ON RB1 REF NO: (B)(4), LOT: SJBDSZ, AND 3-0 ETHIBOND SH REF NO. (B)(4), LOT: TLBEQR, AND WE WERE ABLE TO BREAK IT WITH MEDIUM EFFORT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22555692 ↗
• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UROLOGY PROCEDURE (B)(6) 2025 AND SUTURE WAS USED DURING THE PROCEDURE. I AM WRITING THIS EMAIL TO GIVE SOME FEEDBACK SHARED BY OUR UROLOGY SURGEONS REGARDING THE ETHIBOND 3-0. WE HAVE DONE PENILE PLICATION PROCEDURES RECENTLY, AND FOR THE PAST TWO OCCASIONS, THE 3-0 ETHIBOND RB-1 HAS BEEN BREAKING WHEN THEY ARE TYING A KNOT. WHILE A 3-0 ETHIBOND IS QUITE A SMALL SUTURE, THE SURGEONS BELIEVE IT SHOULD NOT BE BREAKABLE BY THEIR HANDS WHEN TYING A KNOT. WE OPENED TWO SUTURES TODAY, THE 3-0 ETHIBOND ON RB1 REF NO: X872, LOT: SJBDSZ, AND 3-0 ETHIBOND SH REF NO. X832, LOT: TLBEQR, AND WE WERE ABLE TO BREAK IT WITH MEDIUM EFFORT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22555691 ↗
• MalfunctionMay 4, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283365 ↗
• MalfunctionApr 11, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN STAFF OPENED THE BOX THAT FOUR OF THE PACKAGES OF SUTURE WERE PUNCTURED. ANOTHER BOX OF SUTURE WAS OPENED 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 14077481 ↗
• MalfunctionApr 11, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 03/17/2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN STAFF OPENED THE BOX THAT FOUR OF THE PACKAGES OF SUTURE WERE PUNCTURED. ANOTHER BOX OF SUTURE WAS OPENED 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 14077407 ↗
• MalfunctionApr 11, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN STAFF OPENED THE BOX THAT FOUR OF THE PACKAGES OF SUTURE WERE PUNCTURED. ANOTHER BOX OF SUTURE WAS OPENED 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 14077376 ↗
• MalfunctionApr 11, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN STAFF OPENED THE BOX THAT FOUR OF THE PACKAGES OF SUTURE WERE PUNCTURED. ANOTHER BOX OF SUTURE WAS OPENED TO CONTINUE WITH THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14077369 ↗
• MalfunctionJun 20, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE ON 5/23/2019 AND SUTURE WAS USED. THE SUTURE DETACHED FROM THE NEEDLE AT THE SWAGE. THE NEEDLE WAS LOST IN THE PATIENT. A RADIOGRAPHER USED THE IMAGE INTENSIFIER TO REMOVE THE DEVICE FROM THE CHEST WALL DURING THE SAME PROCEDURE. THE PATIENT WAS EXPOSED TO RADIATION (8.44MCG) WITH NO COMPLICATIONS SO FAR. THE PROCEDURE TIME WAS DELAYED BY 20 MINUTES. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8717126 ↗
• MalfunctionJun 20, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE DETACHED FROM THE NEEDLE AT THE SWAGE. THE NEEDLE WAS REMOVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS EXTENDED BY 20 MINUTES. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8717124 ↗
• MalfunctionMar 29, 2019Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A PROCEDURE TO CREATE A POUCH INTRA MUSCULAR ON (B)(6) 2019 AND SUTURE WAS USED. POST- OPERATIVELY THE SUTURE WAS OBSERVED TO HAVE CREATED ENTRAPMENT OF THE BOWEL, AND THE SUTURE WAS SPIT AND APPEARED CUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8465744 ↗
• MalfunctionNov 19, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE TYING THE KNOT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8084757 ↗

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-0153-2027 · Sep 8, 2026 · Open, Classified
  PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H
• Z-1516-2025 · Mar 7, 2025 · Open, Classified
  ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
• 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
• 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
• 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 approx
• 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.