ETHILON 1674HRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031001930), received between Oct 17, 2018 and May 19, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE PULLING THE NEEDLE, SUTURE AND NEEDLE WAS DETACHED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25217126 ↗
• MalfunctionJan 23, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE DEVICE WAS EASY TO BREAK. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18562871 ↗
• MalfunctionJan 23, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE DEVICE WAS EASY TO BREAK. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18562865 ↗
• MalfunctionAug 24, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE ON (B)(6) 2020 AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10445834 ↗
• MalfunctionAug 24, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE ON (B)(6) 2020 AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10445744 ↗
• MalfunctionMar 10, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT BREAKING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9814526 ↗
• MalfunctionNov 20, 2018Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A PROCEDURE FOR A WASHOUT AND INCISION AND DRAINAGE OF RIGHT WOUND INFECTION ON AN UNKNOWN DAY IN (B)(6) 2018 AND SUTURE WAS USED. SURGEON WAS USING SUTURE 2-0 ETHILON WHEN SHE STATED THE TIP BROKE OFF INSIDE THE PATIENT. THE SCRUB TECHNICIAN, SURGEON, AND PA WERE ABLE TO LOCATE THE TIP OF THE NEEDLE. ALL THREE VERIFIED THEY FOUND BOTH PIECES. THE TIP AND REST OF THE NEEDLE WERE BAGGED. THE DEVICE IS NOT AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8089993 ↗
• MalfunctionOct 17, 2018Break

  SURGEON WAS USING SUTURE 2-0 ETHILON WHEN SHE STATED THE TIP BROKE OFF INSIDE THE PATIENT. THE SCRUB TECHNICIAN, SURGEON, AND PA WERE ABLE TO FIND THE TIP OF THE NEEDLE. ALL THREE VERIFIED THEY FOUND BOTH PIECES. THE TIP AND REST OF THE NEEDLE WERE PLACED IN A SEPARATE SPONGE COUNTER OFF THE FIELD. THE SPONGE COUNTER WAS PLACED IN A BIOHAZARD BAG WITH A PATIENT LABEL AND PUT IN THE MANAGERS OFFICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7973120 ↗

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-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-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-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.