ETHICON G123HRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031037458), received between Oct 16, 2018 and Oct 22, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT THE NEEDLE BROKE ON THE SUTURE. NO OTHER INFORMATION WAS GIVEN. THERE WAS NO PATIENT INVOLVEMENT. PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360904 ↗
• MalfunctionSep 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORM, (B)(4), DURING CESAREAN SECTION PROCEDURE, A PATIENT IN THE OR FOR A C-SECTION, THE DEVICE WAS FAILED - SUTURE, AFTER BEING USED, BROKE OFF AT THE NEEDLE. THIS WAS TAKEN OFF THE FIELD IMMEDIATELY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22979098 ↗
• MalfunctionAug 7, 2025Break

  FROM STAFF: A PATIENT IN THE OPERATING ROOM FOR A C-SECTION. SUTURE, AFTER BEING USED, BROKE OFF AT THE NEEDLE. THIS WAS TAKEN OFF THE FIELD IMMEDIATELY.

  Patient problems: Insufficient Information

  MAUDE report 22736601 ↗
• MalfunctionMar 25, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. WHILE SUTURING THE UTERUS, THE NEEDLE POPPED OFF THE SUTURE, INTO THE PATIENT. THE SAME NEEDLE WAS FOUND AND REMOVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13901724 ↗
• MalfunctionFeb 16, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HEMORRHOIDECTOMY ON (B)(6) 2021 AND SUTURE WAS USED. WHEN THE SURGEON WAS PULLING THE NEEDLE THROUGH TISSUE IT BROKE IN HALF INSIDE THE PATIENT. THE SURGEON HAD TO MAKE ANOTHER INCISION TO REMOVE THE BROKEN PIECE. THE PIECE WAS LOCATED BY X-RAYING THE PATIENT. THE PATIENT IS DOING WELL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11333729 ↗
• MalfunctionMar 24, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. THE SUTURE WAS FRAYING WHEN BEING USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9874001 ↗
• MalfunctionFeb 27, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. THE SUTURE WAS FRAYING WHEN BEING USED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9766071 ↗
• InjuryJan 13, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TONSILLECTOMY PROCEDURE AND SUTURE WAS USED. THE SUTURE WAS USED ON THE SOFT PALATE AND THE NEEDLE BROKE OFF AND FELL INTO THE PATIENT. THE PIECES OF THE NEEDLE WERE FOUND AND RETRIEVED BY CUTTING AWAY ADDITIONAL TISSUE AND RETRIEVED WITH A NEEDLE HOLDER. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE. THE CURRENT CONDITION OF THE PATIENT IS REPORTED AS GOOD CONDITION.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9580431 ↗
• MalfunctionAug 28, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE BROKE DURING WOUND CLOSURE. A LIKE DEVICE WAS USED TO COMPLETE THE CLOSURE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8939566 ↗
• MalfunctionAug 28, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE BROKE DURING WOUND CLOSURE. A LIKE DEVICE WAS USED TO COMPLETE THE CLOSURE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8939559 ↗
• MalfunctionMay 17, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED WHAT SEEMS TO BE, A SMALL BUG WAS NOTICED IN THE OUTER STERILE PACKAGING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8620901 ↗
• MalfunctionOct 16, 2018Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A CESAREAN SECTION ON (B)(6) 2018 AND SUTURE WAS USED. WHILE STITCHING WITH SUTURE NEEDLE BROKE WHEN PASSING THE NEEDLE. THE COMPLETE NEEDLE WAS EXTRACTED BY SURGEON. NO ADVERSE CONSEQUENCES TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7969489 ↗

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.