ETHILON 1667HRecalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10705031001824), received between Nov 29, 2018 and Apr 20, 2026 — classified as 40 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT A PROVIDER WAS DOING A SKIN SURGERY AND CLOSING THE WOUND WITH SUTURE. BEFORE STARTING THE CLOSURE, SHE NOTICED THE TIP OF THE NEEDLE BROKE OFF. NO DELAY OR PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925488 ↗
• MalfunctionOct 9, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE CUSTOMER IS REPORTING FROM NURSES/PHYSICIANS THAT THE SUTURES FROM THE TWO LOT'S KEEP BREAKING MID SOW AND CUTTING THROWING THE SKIN WHILE NOT GUIDING THROUGH CORRECTLY. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409056 ↗
• MalfunctionNov 10, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE THREAD KEEPS BREAKING WHILE IN USE. NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18113552 ↗
• MalfunctionSep 5, 2023Break; Break

  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 BY THE DISTRIBUTOR PER THEIR CUSTOMER: ¿NYLON SUTURE DAMAGED.¿ IT IS UNKNOWN WHAT TYPE OF DAMAGE IT IS. IT IS UNKNOWN IF THERE WERE ANY PATIENT CONSEQUENCES. THE DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17687484 ↗
• MalfunctionApr 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WRIST FRACTURE PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2023 AND SUTURE WAS USED. THE THREAD WAS BREAKING APART FROM THE NEEDLE WITH VERY LITTLE FORCE APPLIED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16713265 ↗
• InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED STAPH AND ECOLI, DUE TO THE PRODUCT BUT DID NOT REQUIRE HOSPITALIZATION NOR FOLLOW UP TREATMENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS IN GOOD HEALTH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15822662 ↗
• InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED STAPH AND ECOLI, DUE TO THE PRODUCT BUT DID NOT REQUIRE HOSPITALIZATION NOR FOLLOW UP TREATMENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS IN GOOD HEALTH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15822560 ↗
• InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED STAPH AND ECOLI, DUE TO THE PRODUCT BUT DID NOT REQUIRE HOSPITALIZATION NOR FOLLOW UP TREATMENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS IN GOOD HEALTH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15822514 ↗
• InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED STAPH AND ECOLI, DUE TO THE PRODUCT BUT DID NOT REQUIRE HOSPITALIZATION NOR FOLLOW UP TREATMENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS IN GOOD HEALTH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15822513 ↗
• InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED STAPH AND ECOLI, DUE TO THE PRODUCT BUT DID NOT REQUIRE HOSPITALIZATION NOR FOLLOW UP TREATMENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS IN GOOD HEALTH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15822008 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED STAPH AND ECOLI, DUE TO THE PRODUCT BUT DID NOT REQUIRE HOSPITALIZATION NOR FOLLOW UP TREATMENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS IN GOOD HEALTH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15821769 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED STAPH AND ECOLI, DUE TO THE PRODUCT BUT DID NOT REQUIRE HOSPITALIZATION NOR FOLLOW UP TREATMENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS IN GOOD HEALTH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15821756 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED STAPH AND ECOLI, DUE TO THE PRODUCT BUT DID NOT REQUIRE HOSPITALIZATION NOR FOLLOW UP TREATMENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS IN GOOD HEALTH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15819852 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED STAPH AND ECOLI, DUE TO THE PRODUCT BUT DID NOT REQUIRE HOSPITALIZATION NOR FOLLOW UP TREATMENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS IN GOOD HEALTH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15819673 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED STAPH AND ECOLI, DUE TO THE PRODUCT BUT DID NOT REQUIRE HOSPITALIZATION NOR FOLLOW UP TREATMENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS IN GOOD HEALTH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15819551 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED STAPH AND ECOLI, DUE TO THE PRODUCT BUT DID NOT REQUIRE HOSPITALIZATION NOR FOLLOW UP TREATMENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS IN GOOD HEALTH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15818724 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED STAPH AND ECOLI, DUE TO THE PRODUCT BUT DID NOT REQUIRE HOSPITALIZATION NOR FOLLOW UP TREATMENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS IN GOOD HEALTH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15818717 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED STAPH AND ECOLI, DUE TO THE PRODUCT BUT DID NOT REQUIRE HOSPITALIZATION NOR FOLLOW UP TREATMENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS IN GOOD HEALTH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15818649 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED STAPH AND ECOLI, DUE TO THE PRODUCT BUT DID NOT REQUIRE HOSPITALIZATION NOR FOLLOW UP TREATMENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS IN GOOD HEALTH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15818577 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED STAPH AND ECOLI, DUE TO THE PRODUCT BUT DID NOT REQUIRE HOSPITALIZATION NOR FOLLOW UP TREATMENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS IN GOOD HEALTH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15818371 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED STAPH AND ECOLI, DUE TO THE PRODUCT BUT DID NOT REQUIRE HOSPITALIZATION NOR FOLLOW UP TREATMENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS IN GOOD HEALTH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15818141 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED STAPH AND ECOLI, DUE TO THE PRODUCT BUT DID NOT REQUIRE HOSPITALIZATION NOR FOLLOW UP TREATMENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS IN GOOD HEALTH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15818018 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED STAPH AND ECOLI, DUE TO THE PRODUCT BUT DID NOT REQUIRE HOSPITALIZATION NOR FOLLOW UP TREATMENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS IN GOOD HEALTH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15817965 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED STAPH AND ECOLI, DUE TO THE PRODUCT BUT DID NOT REQUIRE HOSPITALIZATION NOR FOLLOW UP TREATMENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS IN GOOD HEALTH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15817886 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DERMATOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED STAPH AND ECOLI, DUE TO THE PRODUCT BUT DID NOT REQUIRE HOSPITALIZATION NOR FOLLOW UP TREATMENT. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS IN GOOD HEALTH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15817866 ↗

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.