ETHICON G122HRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10705031037441), received between Jan 26, 2018 and Jun 30, 2026 — classified as 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (12 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE TIP OF THE SUTURE BREAKS OFF WHEN SUTURING. RECURRING; HAPPENS EVERY SINGLE USE (CLINIC USES ABOUT 30 PER WEEK). PRODUCT IS NOT MODIFIED AND IS USED CORRECTLY ACCORDING TO VENDOR INSTRUCTIONS. THE CLINIC HAS NEVER HAD THIS PROBLEM BEFORE WITH THIS PRODUCT ("SOMETHING HAS CHANGED"). CLINIC IS ACCOUNTING FOR THE BROKEN TIPS, USING ADDITIONAL SUTURES TO COMPLETE PROCEDURES, AND IS ACTIVELY SOURCING NEW SUTURES. DOCTOR WOULD ALSO LIKE TO ADD HE HAS BEEN PRACTICING SURGERY FOR MORE THAN 25 YEARS, BOTH IN HIS PRIVATE SEDATION CLINIC AND AT THE NORTHERN REGIONAL HOSPITAL, AND HAS NEVER ENCOUNTERED THIS TYPE OF PROBLEM WITH ANY SUTURES DURING HIS CAREER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25665103 ↗
• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT IN 2 CASES THEY HAD A NEEDLE BREAK. AN X RAY WAS DONE BUT WERE NOT ABLE TO BE FOUND. THERE WAS NO ISSUES WITH THE PATIENTS. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25201897 ↗
• MalfunctionApr 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE ACCOUNT CONTACT TO THE SALES REP THAT DURING A BILATERAL SALPINGECTOMY PROCEDURE, THE NEEDLE BROKE WHEN THEY ARE CLOSING THE SUBCUTANEOUS TISSUE. NO PATIENT CONSEQUENCES. DEVICE WILL BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049064 ↗
• MalfunctionApr 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING PATIENT PROCEDURE, CHROMIC GUT SUTURE 3-0 SH WAS BEING USED. NEEDLE BROKE OFF OF THE SUTURE IN THE PATIENT. DOCTOR AND ASSIST WERE UNABLE TO SEE OR FEEL THE SUTURE IN THE MUSCLE, REQUIRING FURTHER DISSECTION TO FIND THE NEEDLE. APPROXIMATELY 20 MINUTES EXTRA TIME WAS REQUIRED TO LOCATE THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877666 ↗
• MalfunctionAug 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SEEM TO BE BREAKING EASIER THAN THEY SHOULD DURING SURGICAL PROCEDURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783322 ↗
• MalfunctionAug 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SEEM TO BE BREAKING EASIER THAN THEY SHOULD DURING SURGICAL PROCEDURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783318 ↗
• MalfunctionNov 21, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED BY THE ACCOUNT CONTACT THAT ON (B)(6) 2024 WHEN THEIR ORDER WAS DELIVERED VIA OLD DOMINION THAT THE OUTSIDE SHIPPING BOX AND THE INSIDE SUTURE BOXES WERE CRUSHED. BOX WAS ON A PALLET WITH THE REST OF THEIR ORDER. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20746931 ↗
• MalfunctionDec 21, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, CUSTOMER REPORTED THAT THESE SUTURES ARE LISTED AS A 3-0 AND ARE SIZED LIKE A 4-0. A TOTAL 12 OF THE SUTURES OUT OF THE BOX, ALL SEEMED TO BE DEFECTIVE. DEVICES ARE AVAILABLE TO RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18377728 ↗
• MalfunctionDec 20, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, CUSTOMER REPORTED THAT THESE SUTURES ARE LISTED AS A 3-0 AND ARE SIZED LIKE A 4-0. A TOTAL 12 OF THE SUTURES OUT OF THE BOX, ALL SEEMED TO BE DEFECTIVE. DEVICES ARE AVAILABLE TO RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367563 ↗
• MalfunctionDec 20, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, CUSTOMER REPORTED THAT THESE SUTURES ARE LISTED AS A 3-0 AND ARE SIZED LIKE A 4-0. A TOTAL 12 OF THE SUTURES OUT OF THE BOX, ALL SEEMED TO BE DEFECTIVE. DEVICES ARE AVAILABLE TO RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367555 ↗
• MalfunctionDec 20, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, CUSTOMER REPORTED THAT THESE SUTURES ARE LISTED AS A 3-0 AND ARE SIZED LIKE A 4-0. A TOTAL 12 OF THE SUTURES OUT OF THE BOX, ALL SEEMED TO BE DEFECTIVE. DEVICES ARE AVAILABLE TO RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367552 ↗
• MalfunctionDec 20, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, CUSTOMER REPORTED THAT THESE SUTURES ARE LISTED AS A 3-0 AND ARE SIZED LIKE A 4-0. A TOTAL 12 OF THE SUTURES OUT OF THE BOX, ALL SEEMED TO BE DEFECTIVE. DEVICES ARE AVAILABLE TO RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367549 ↗
• MalfunctionDec 20, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, CUSTOMER REPORTED THAT THESE SUTURES ARE LISTED AS A 3-0 AND ARE SIZED LIKE A 4-0. A TOTAL 12 OF THE SUTURES OUT OF THE BOX, ALL SEEMED TO BE DEFECTIVE. DEVICES ARE AVAILABLE TO RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367547 ↗
• MalfunctionDec 20, 2023Component Misassembled; Component Misassembled

  CUSTOMER REPORTED THAT PER DR. WILKINSON, THESE SUTURES ARE LISTED AS A 3-0 AND ARE SIZED LIKE A 4-0. NO PATIENT HARM. DEVICES ARE AVAILABLE TO RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367545 ↗
• MalfunctionDec 20, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, CUSTOMER REPORTED THAT THESE SUTURES ARE LISTED AS A 3-0 AND ARE SIZED LIKE A 4-0. A TOTAL 12 OF THE SUTURES OUT OF THE BOX, ALL SEEMED TO BE DEFECTIVE. DEVICES ARE AVAILABLE TO RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367539 ↗
• MalfunctionDec 20, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, CUSTOMER REPORTED THAT THESE SUTURES ARE LISTED AS A 3-0 AND ARE SIZED LIKE A 4-0. A TOTAL 12 OF THE SUTURES OUT OF THE BOX, ALL SEEMED TO BE DEFECTIVE. DEVICES ARE AVAILABLE TO RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367537 ↗
• MalfunctionDec 20, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, CUSTOMER REPORTED THAT THESE SUTURES ARE LISTED AS A 3-0 AND ARE SIZED LIKE A 4-0. A TOTAL 12 OF THE SUTURES OUT OF THE BOX, ALL SEEMED TO BE DEFECTIVE. DEVICES ARE AVAILABLE TO RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367536 ↗
• MalfunctionDec 20, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, CUSTOMER REPORTED THAT THESE SUTURES ARE LISTED AS A 3-0 AND ARE SIZED LIKE A 4-0. A TOTAL 12 OF THE SUTURES OUT OF THE BOX, ALL SEEMED TO BE DEFECTIVE. DEVICES ARE AVAILABLE TO RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367528 ↗
• MalfunctionDec 20, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, CUSTOMER REPORTED THAT THESE SUTURES ARE LISTED AS A 3-0 AND ARE SIZED LIKE A 4-0. A TOTAL 12 OF THE SUTURES OUT OF THE BOX, ALL SEEMED TO BE DEFECTIVE. DEVICES ARE AVAILABLE TO RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367527 ↗
• MalfunctionSep 22, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RHYTIDECTOMY PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE GOT DETACHED FROM THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12514173 ↗
• MalfunctionSep 22, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RHYTIDECTOMY PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12514091 ↗
• MalfunctionJul 30, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, A SMALL PIECE OF HAIR WAS INSIDE THE PACKAGE WHEN THEY OPENED THEIR SUTURE. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12256312 ↗
• MalfunctionAug 11, 2020Break; Break

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10390663 ↗
• MalfunctionApr 30, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PREMATURELY DETACHED FROM THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7472360 ↗
• MalfunctionApr 30, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PREMATURELY DETACHED FROM THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7472358 ↗

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.