ETHILON 699GRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10705031008625), received between Apr 25, 2018 and Apr 6, 2026 — classified as 3 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Material Separation” (23 reports).

1 FDA recall record name this device's identifier, 1 still open.

7 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.

Recalls naming this device

1. Dec 20, 2024Open, Classified

   Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

   Z-1097-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE DETACHED FROM THE NEEDLE DURING SUTURING AND HAD TO REDO. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790383 ↗
• MalfunctionApr 6, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, SUTURE DETACHED FROM THE NEEDLE DURING SUTURING AND HAD TO REDO. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790382 ↗
• MalfunctionAug 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING SUTURING. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22688063 ↗
• MalfunctionJun 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY WHEN HELD THE NEEDLE WITH THE NEEDLE-HOLDER. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184804 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A SKIN REACTION A WEEK OR TWO WEEKS AFTER THE PROCEDURE. THE PATIENT HAD SWELLING AND THE SKIN WAS RAISED WITH A LITTLE BIT OF DRAINAGE. THE PATIENTS WAS TREATED WITH ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 21503902 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXCISION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A SKIN REACTION A WEEK OR TWO WEEKS AFTER THE PROCEDURE. THE PATIENT HAD SWELLING AND THE SKIN WAS RAISED WITH A LITTLE BIT OF DRAINAGE. THE PATIENTS WAS TREATED WITH ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 21503893 ↗
• MalfunctionJan 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL, THAT THE SURGEON WAS SUTURING THE PICC LINE WHEN PUT THE NEEDLE IN THE SKIN AND THE THREAD CAME OFF THE NEEDLE. HAD GET A NEW SUTURE AND POKE AGAIN. THE DEVICE WAS NOT AVAILABLE FOR RETURN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21081927 ↗
• MalfunctionApr 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST LUMPECTOMY ON AN UNKNOWN DATE. POST-OP, THE PATIENT CAME IN WITH BLEEDING FROM THE BREAST LUMPECTOMY SITE; LOCAL ANESTHESIA WAS PLACED, LIDOCAINE 1% WITH EPINEPHRINE, 5ML AT WOUND SITE. WHEN ATTEMPTING TO PLACE INITIAL SUTURE AT WORST SITE OF BLEEDING (INFERIOR WOUND EDGE), THE NEEDLE TIP EMBEDDED IN TISSUE AND WHILE TRYING TO REACH OPPOSITE WOUND EDGE, THERE WAS A SNAPPING SOUND AND NEEDLE BECAME DISCONNECTED FROM SUTURE AND FULLY EMBEDDED IN TISSUE, NOT VISIBLE OR RETRIEVABLE BY HEMOSTAT. SUTURE NOT TO EXPIRE UNTIL 2026. HEMOSTASIS WAS ACHIEVED WITH A DIFFERENT SUTURE. THE DOCTOR THEN EXPLAINED TO PATIENT THAT THEY COULD NOT LOCATE NEEDLE AND ADVISED THAT PATIENT GO TO ER WHERE AN ADDITIONAL STERI-STRIP WAS PLACED OVER THE SUPERIOR ASPECT OF THE WOUND DEHISCENCE. THE PATIENT WAS ALSO ADVISED TO FOLLOW UP WITH HER BREAST SURGEON. NO FURTHER INFORMATION COULD BE PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16681929 ↗
• MalfunctionApr 3, 2023Break; Break

  IT WAS REPORTED A PATIENT WENT TO URGENT CARE ON AN UNKNOWN DATE AND SUTURE WAS USED. PATIENT POST LUMPECTOMY AND WAS BLEEDING, WENT TO URGENT CARE, FELT THE NEEDLE SNAP, COULDN'T FIND THE NEEDLE. THE ER CANNOT FIND THE NEEDLE ANYWHERE IN THE PATIENT WITH IMAGING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16663626 ↗
• MalfunctionMar 31, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16654790 ↗
• MalfunctionFeb 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DENTAL AND ORAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE AND THE NEEDLE FELL INTO INTRAORAL. THE NEEDLE PIECE REMOVED FROM THE PATIENT DURING THE SAME PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375631 ↗
• MalfunctionDec 7, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE AND THIS HAPPENED TWO TIMES IN A ROW. THE EVENT OCCURRED WHEN AN EPIDERMAL SUTURE WAS PERFORMED FOR THE PATIENT WHO CUT THE PATIENT¿S HAND WITH A CHISEL. THESE WERE NOT CONTROL RELEASE NEEDLES. THE SURGEON HAS USED PRODUCT FOR A LONG TIME AND THIS WAS THE FIRST TIME SOMETHING LIKE THIS HAPPENED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15932826 ↗
• MalfunctionDec 7, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE AND THIS HAPPENED TWO TIMES IN A ROW. THE EVENT OCCURRED WHEN AN EPIDERMAL SUTURE WAS PERFORMED FOR THE PATIENT WHO CUT THE PATIENT¿S HAND WITH A CHISEL. THESE WERE NOT CONTROL RELEASE NEEDLES. THE SURGEON HAS USED PRODUCT FOR A LONG TIME AND THIS WAS THE FIRST TIME SOMETHING LIKE THIS HAPPENED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15932742 ↗
• MalfunctionDec 16, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN DENTAL AND ORAL SURGERY ON (B)(6), 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019653 ↗
• MalfunctionSep 22, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOLOGIC SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED (BROKEN) FROM THE SWAGE PART OF THE NEEDLE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12512766 ↗
• MalfunctionJun 4, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. WHEN PUTTING A STITCH ON THE ACHILLES TENDON, THE NEEDLE WAS BROKEN AT THE SWAGE PART. NO EXTRA FORCE WAS APPLIED, AND IT WAS NOT USED IN A DIFFERENT WAY THAN USUAL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939659 ↗
• MalfunctionOct 21, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOLOGIC SURGERY ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE ON THE EPIDERMIS. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10712406 ↗
• MalfunctionOct 21, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOLOGIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE ON THE EPIDERMIS. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THE LOT NUMBER IS UNKNOWN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10712349 ↗
• MalfunctionOct 21, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOLOGIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE ON THE EPIDERMIS. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THE LOT NUMBER IS UNKNOWN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10712245 ↗
• MalfunctionOct 21, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOLOGIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE ON THE EPIDERMIS. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THE LOT NUMBER IS UNKNOWN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10712187 ↗
• MalfunctionMay 20, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE WAS BROKEN AT THE SWAGE PART DURING USE. FURTHER DETAILS WERE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10076193 ↗
• MalfunctionJan 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A NEPHROLOGY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE DURING INTERRUPTED SUTURING, AND THE SUTURE FELL. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9582226 ↗
• MalfunctionNov 6, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BIOPSY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. IT WAS REPORTED THAT UPON THE TIME OF ENTERING THE PATIENT THE SUTURE HAD BROKEN OFF AT THE SUTURE NEEDLE CONNECTION. THE NEEDLE WAS NO LONGER VISIBLE IN THE PATIENT BUT WAS ABLE TO BE FELT. AFTER SEARCHING INSIDE THE PATIENTS LEG IT WAS ABLE TO BE PUSHED THROUGH AND PULLED OUT THE OTHER SIDE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9285036 ↗
• MalfunctionOct 28, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE CAME APART WHILE THE PHYSICIAN WAS TRYING TO USE IT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9243781 ↗
• MalfunctionOct 28, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE CAME APART WHILE THE PHYSICIAN WAS TRYING TO USE IT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9243780 ↗

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-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.