ETHILON 2819GRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031004047), received between Jun 30, 2020 and Dec 1, 2022 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. AT THE TIME OF LIGATION, A SUTURE BROKE DURING SUTURING ON A NERVE. THEREFORE, A SUTURE FROM ANOTHER PRODUCT CODE WAS USED INSTEAD AND THAT SUTURE ALSO BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15900480 ↗
• MalfunctionMar 30, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT PRE-OP TO UNKNOWN SURGERY IN 2020 WHEN OPENING THE SAMPLES, IT WAS FOUND THAT THE NEEDLES ARE DIFFERENT BECAUSE THE NEEDLE OF CODE 2819G LOOKS LIKE A TYPE SKI NEEDLE RATHER THAN THE CURVED NEEDLE OF THE FG2819 NEEDLE. THE NEEDLE OF CODE 2819G IS DIFFERENT BECAUSE IT IS BIGGER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11591253 ↗
• MalfunctionMar 30, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT PRE-OP TO UNKNOWN SURGERY IN 2020 WHEN OPENING THE SAMPLES, IT WAS FOUND THAT THE NEEDLES ARE DIFFERENT BECAUSE THE NEEDLE OF CODE 2819G LOOKS LIKE A TYPE SKI NEEDLE RATHER THAN THE CURVED NEEDLE OF THE FG2819 NEEDLE. THE NEEDLE OF CODE 2819G IS DIFFERENT BECAUSE IT IS BIGGER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11591198 ↗
• MalfunctionMar 30, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT PRE-OP TO UNKNOWN SURGERY IN 2020 WHEN OPENING THE SAMPLES, IT WAS FOUND THAT THE NEEDLES ARE DIFFERENT BECAUSE THE NEEDLE OF CODE 2819G LOOKS LIKE A TYPE SKI NEEDLE RATHER THAN THE CURVED NEEDLE OF THE FG2819 NEEDLE. THE NEEDLE OF CODE 2819G IS DIFFERENT BECAUSE IT IS BIGGER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11591189 ↗
• MalfunctionMar 30, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT PRE-OP TO UNKNOWN SURGERY IN 2020 WHEN OPENING THE SAMPLES, IT WAS FOUND THAT THE NEEDLES ARE DIFFERENT BECAUSE THE NEEDLE OF CODE 2819G LOOKS LIKE A TYPE SKI NEEDLE RATHER THAN THE CURVED NEEDLE OF THE FG2819 NEEDLE. THE NEEDLE OF CODE 2819G IS DIFFERENT BECAUSE IT IS BIGGER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11591188 ↗
• MalfunctionMar 30, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT PRE-OP TO UNKNOWN SURGERY IN 2020 WHEN OPENING THE SAMPLES, IT WAS FOUND THAT THE NEEDLES ARE DIFFERENT BECAUSE THE NEEDLE OF CODE 2819G LOOKS LIKE A TYPE SKI NEEDLE RATHER THAN THE CURVED NEEDLE OF THE FG2819 NEEDLE. THE NEEDLE OF CODE 2819G IS DIFFERENT BECAUSE IT IS BIGGER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11591187 ↗
• MalfunctionMar 30, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT PRE-OP TO UNKNOWN SURGERY IN 2020 WHEN OPENING THE SAMPLES, IT WAS FOUND THAT THE NEEDLES ARE DIFFERENT BECAUSE THE NEEDLE OF CODE 2819G LOOKS LIKE A TYPE SKI NEEDLE RATHER THAN THE CURVED NEEDLE OF THE FG2819 NEEDLE. THE NEEDLE OF CODE 2819G IS DIFFERENT BECAUSE IT IS BIGGER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11591184 ↗
• MalfunctionMar 30, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT PRE-OP TO UNKNOWN SURGERY IN 2020 WHEN OPENING THE SAMPLES, IT WAS FOUND THAT THE NEEDLES ARE DIFFERENT BECAUSE THE NEEDLE OF CODE 2819G LOOKS LIKE A TYPE SKI NEEDLE RATHER THAN THE CURVED NEEDLE OF THE FG2819 NEEDLE. THE NEEDLE OF CODE 2819G IS DIFFERENT BECAUSE IT IS BIGGER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11591178 ↗
• MalfunctionMar 30, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT PRE-OP TO UNKNOWN SURGERY IN 2020 WHEN OPENING THE SAMPLES, IT WAS FOUND THAT THE NEEDLES ARE DIFFERENT BECAUSE THE NEEDLE OF CODE 2819G LOOKS LIKE A TYPE SKI NEEDLE RATHER THAN THE CURVED NEEDLE OF THE FG2819 NEEDLE. THE NEEDLE OF CODE 2819G IS DIFFERENT BECAUSE IT IS BIGGER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11591177 ↗
• MalfunctionOct 1, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PRE-OP TO UNKNOWN SURGERY IN (B)(6) 2020 AT THE OPENING OF SAMPLE, THE NEEDLE DOES NOT MATCH A CORRECT ONE EXPECTED FOR THE PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10617513 ↗
• MalfunctionJun 30, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE OF THE SUTURE FROM THE LOT DOES NOT MATCH WITH THE CORRECT ONE EXPECTED FOR THE PRODUCT CODE. THE CURVE OF THE NEEDLE IS DIFFERENT. IT WAS STATED THE NEEDLE LOOKED LIKE A SKI TYPE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE PATIENT WAS NOT IMPACTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10214481 ↗

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.