ETHILON W2808Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031202467), received between Jul 10, 2024 and Apr 28, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Break; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING SURGERY, THE SUTURE USED FOR VASCULAR REPAIR FAILED, FORCING THE USE OF MULTIPLE PACKINGS. THESE EVIDENCED THE FOLLOWING DEFECTS: SPLIT NEEDLE, BENT NEEDLE, DETACHMENT OF THE NEEDLE THREAD. THESE FAILURES PREVENTED THE EFFECTIVE USE OF THE SUTURE DURING THE SURGICAL PROCEDURE. IT SHOULD BE NOTED THAT FOUR DIFFERENT SUTURES WERE USED, ALL CORRESPONDING TO THE SAME BATCH. IT SHOULD BE NOTED THAT IT WAS A PRODUCT TEST SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO SURGICAL DELAYS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019557 ↗
• MalfunctionApr 28, 2026Break; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING SURGERY, THE SUTURE USED FOR VASCULAR REPAIR FAILED, FORCING THE USE OF MULTIPLE PACKINGS. THESE EVIDENCED THE FOLLOWING DEFECTS: SPLIT NEEDLE, BENT NEEDLE, DETACHMENT OF THE NEEDLE THREAD. THESE FAILURES PREVENTED THE EFFECTIVE USE OF THE SUTURE DURING THE SURGICAL PROCEDURE. IT SHOULD BE NOTED THAT FOUR DIFFERENT SUTURES WERE USED, ALL CORRESPONDING TO THE SAME BATCH. IT SHOULD BE NOTED THAT IT WAS A PRODUCT TEST SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO SURGICAL DELAYS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019457 ↗
• MalfunctionApr 28, 2026Break; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING SURGERY, THE SUTURE USED FOR VASCULAR REPAIR FAILED, FORCING THE USE OF MULTIPLE PACKINGS. THESE EVIDENCED THE FOLLOWING DEFECTS: SPLIT NEEDLE, BENT NEEDLE, DETACHMENT OF THE NEEDLE THREAD. THESE FAILURES PREVENTED THE EFFECTIVE USE OF THE SUTURE DURING THE SURGICAL PROCEDURE. IT SHOULD BE NOTED THAT FOUR DIFFERENT SUTURES WERE USED, ALL CORRESPONDING TO THE SAME BATCH. IT SHOULD BE NOTED THAT IT WAS A PRODUCT TEST SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO SURGICAL DELAYS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019282 ↗
• MalfunctionApr 17, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE KNOTTING ETHILON SUTURE W2808, THE SUTURE KEPT BREAKING IN THE SURGEONS HAND, IT DID NOT BRAKE AWAY AT THE NEEDLE-SUTURE POINT, BUT ALONG THE SUTURE. 5EA BROKE OFF, AND THEY SWITCHED TO A DIFFERENT SUTURE (NOT J&J) TO FINISH THE OPERATION. THE OPERATION WAS PROLONGED FOR 10 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24909977 ↗
• MalfunctionApr 17, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE KNOTTING ETHILON SUTURE W2808, THE SUTURE KEPT BREAKING IN THE SURGEONS HAND, IT DID NOT BRAKE AWAY AT THE NEEDLE-SUTURE POINT, BUT ALONG THE SUTURE. 5EA BROKE OFF, AND THEY SWITCHED TO A DIFFERENT SUTURE (NOT J&J) TO FINISH THE OPERATION. THE OPERATION WAS PROLONGED FOR 10 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24909976 ↗
• MalfunctionApr 17, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE KNOTTING ETHILON SUTURE W2808, THE SUTURE KEPT BREAKING IN THE SURGEONS HAND, IT DID NOT BRAKE AWAY AT THE NEEDLE-SUTURE POINT, BUT ALONG THE SUTURE. 5EA BROKE OFF, AND THEY SWITCHED TO A DIFFERENT SUTURE (NOT J&J) TO FINISH THE OPERATION. THE OPERATION WAS PROLONGED FOR 10 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24909974 ↗
• MalfunctionApr 17, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE KNOTTING ETHILON SUTURE W2808, THE SUTURE KEPT BREAKING IN THE SURGEONS HAND, IT DID NOT BRAKE AWAY AT THE NEEDLE-SUTURE POINT, BUT ALONG THE SUTURE. 5EA BROKE OFF, AND THEY SWITCHED TO A DIFFERENT SUTURE (NOT J&J) TO FINISH THE OPERATION. THE OPERATION WAS PROLONGED FOR 10 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24909973 ↗
• MalfunctionApr 17, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE KNOTTING ETHILON SUTURE W2808, THE SUTURE KEPT BREAKING IN THE SURGEONS HAND, IT DID NOT BRAKE AWAY AT THE NEEDLE-SUTURE POINT, BUT ALONG THE SUTURE. 5EA BROKE OFF, AND THEY SWITCHED TO A DIFFERENT SUTURE (NOT J&J) TO FINISH THE OPERATION. THE OPERATION WAS PROLONGED FOR 10 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24909971 ↗
• MalfunctionApr 16, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THREAD ALWAYS BREAKS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO SURGICAL DELAYS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24903145 ↗
• MalfunctionApr 16, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THREAD ALWAYS BREAKS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO SURGICAL DELAYS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24903120 ↗
• MalfunctionApr 16, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THREAD ALWAYS BREAKS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO SURGICAL DELAYS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24894975 ↗
• MalfunctionApr 16, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THREAD ALWAYS BREAKS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO SURGICAL DELAYS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24894949 ↗
• MalfunctionOct 25, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE SUTURE IS BROKEN WHILE USING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533704 ↗
• MalfunctionJul 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE AND SUTURE SEPARATED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19710603 ↗

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.