ETHICON 1915GRecalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10705031002913), received between May 1, 2018 and Jul 29, 2025 — classified as 8 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Break” (23 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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN APRIL 2025 AND SUTURE WAS USED. PER USER FACILITY MEDWATCH FORM, #MW (B)(4), THAT DURING UNKNOWN PROCEDURE DR. NOTICED THE TIP OF ONE OF THE 5.0 FAST ABSORBING NEEDLE TIP WAS MISSING. STAFF COMPARED IT TO ANOTHER SUTURE AND WAS INDEED MISSING. DR. IMMEDIATELY WENT TO LOOK FOR TIP IN PATIENT'S TONGUE. IT WAS LOCATED AND PLACED INTO A SPECIMEN CUP. XRAY ORDERED TO CONFIRM THERE WAS NO REMAINING SUTURE. XRAY READ BY DR. DID NOT SEE ANY RESIDUAL SUTURE LEFT IN THE TONGUE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE AVAILABILITY IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22649497 ↗
• MalfunctionJun 30, 2025Activation, Positioning or Separation Problem

  DR. (B)(6) NOTICED THE TIP OF ONE OF THE 5.0 FAST ABSORBING NEEDLE TIP WAS MISSING. STAFF COMPARED IT TO ANOTHER SUTURE AND WAS INDEED MISSING. DR. (B)(6) IMMEDIATELY WENT TO LOOK FOR TIP IN PATIENT'S TONGUE. IT WAS LOCATED AND PLACED INTO A SPECIMEN CUP. XRAY ORDERED TO CONFIRM THERE WAS NO REMAINING SUTURE. XRAY READ BY DR. (B)(6) DID NOT SEE ANY RESIDUAL SUTURE LEFT IN THE TONGUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22352627 ↗
• MalfunctionApr 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON WAS USING THE STITCHES THE NEEDLE WAS SEPARATING FROM THE SUTURE. THIS IS FOR TWO BOXES WITHIN THE SAME LOT. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866291 ↗
• MalfunctionApr 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON WAS USING THE STITCHES THE NEEDLE WAS SEPARATING FROM THE SUTURE. THIS IS FOR TWO BOXES WITHIN THE SAME LOT. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866287 ↗
• MalfunctionDec 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LACERATION CLOSURE PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE PHYSICIAN HAD 2 SUTURES BREAK AT THE SWAGE WHILE CLOSING A LACERATION. AFTER ONE OF THE SUTURE/NEEDLE SEPARATIONS, THE NEEDLE WAS WITHIN THE WOUND BUT WAS EASILY FOUND AND RETRIEVED FROM THE WOUND. PHYSICIAN ENDED UP USING A 3RD SUTURE TO COMPLETE THE LACERATION REPAIR SUCCESSFULLY. DEVICES WERE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20890858 ↗
• MalfunctionDec 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LACERATION CLOSURE PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE PHYSICIAN HAD 2 SUTURES BREAK AT THE SWAGE WHILE CLOSING A LACERATION. AFTER ONE OF THE SUTURE/NEEDLE SEPARATIONS, THE NEEDLE WAS WITHIN THE WOUND BUT WAS EASILY FOUND AND RETRIEVED FROM THE WOUND. PHYSICIAN ENDED UP USING A 3RD SUTURE TO COMPLETE THE LACERATION REPAIR SUCCESSFULLY. DEVICES WERE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20890857 ↗
• MalfunctionApr 16, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE APART WHILE ATTEMPTING TO SUTURE PATIENT'S FOREHEAD. CHANGED TO ANOTHER ONE BUT THE SAME THING HAPPENED AGAIN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116411 ↗
• MalfunctionApr 16, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE APART WHILE ATTEMPTING TO SUTURE PATIENT'S FOREHEAD. CHANGED TO ANOTHER ONE BUT THE SAME THING HAPPENED AGAIN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116410 ↗
• MalfunctionJan 19, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, ¿WHILE ATTEMPTING TO CLOSE A SKIN INCISION WITH THE ABOVE SUTURE, THE SUTURE NEEDLE BROKE AWAY FROM THE SUTURE AND WAS POSSIBLY LEFT INSIDE THE SKIN. WHILE WE WAIT FOR CONFIRMATORY SCANS AS TO THE LOCATION OF THE NEEDLE, WE ARE INQUIRING IF THIS PATIENT CAN HAVE AN MRI. WE ARE UNSURE IF THE SUTURE NEEDLE IS SAFE FOR MRI.¿ THE DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18547957 ↗
• MalfunctionDec 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT THE NEEDLE BROKE OFF STRING DURING RUNNING STITCH. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ONE DEVICE WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18307713 ↗
• MalfunctionNov 15, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BLEPHAROPLASTY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BREAKING WHILE SUTURING EYE LID TISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE PATIENT IS CURRENTLY DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145225 ↗
• MalfunctionNov 15, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BLEPHAROPLASTY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BREAKING WHILE SUTURING EYE LID TISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE PATIENT IS CURRENTLY DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145222 ↗
• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYELID PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED A BAD REACTION TO THE SUTURE, AS DIAGNOSED BY AN OPHTHALMOLOGIST. THE PATIENT DEVELOPED MULTIPLE CYSTS ABOVE THE SUTURE LINE. THE PATIENT DID NOT IMPROVE WITH INCISION AND DRAINAGE, TOPICAL STEROID, OR MEDROL. THERE WAS SLIGHT IMPROVEMENT WITH STEROID INJECTIONS. THE PATIENT FINALLY IMPROVED AFTER MINOCYCLINE TAKEN ORALLY FOR 7 DAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Cyst(s); Hypersensitivity/Allergic reaction

  MAUDE report 17342264 ↗
• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYELID PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED A BAD REACTION TO THE SUTURE, AS DIAGNOSED BY AN OPHTHALMOLOGIST. THE PATIENT HAD PROLONGED CHEMOSIS. THE PATIENT WAS TOLD BY THE OPHTHALMOLOGIST THAT THEY HAD AN ALLERGY TO THE SUTURE MATERIAL. THE PATIENT¿S SYMPTOMS RESOLVED AFTER STEROID DROPS AND MEDROL DOSE PACK OVER A FEW MONTHS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 17342252 ↗
• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYELID PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED A BAD REACTION TO THE SUTURE, AS DIAGNOSED BY AN OPHTHALMOLOGIST. THE PATIENT DEVELOPED MULTIPLE CYSTS ABOVE THE SUTURE LINE. THE PATIENT DID NOT IMPROVE WITH INCISION AND DRAINAGE, TOPICAL STEROID, OR MEDROL. THERE WAS SLIGHT IMPROVEMENT WITH STEROID INJECTIONS. THE PATIENT FINALLY IMPROVED AFTER MINOCYCLINE TAKEN ORALLY FOR 7 DAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Cyst(s); Hypersensitivity/Allergic reaction

  MAUDE report 17342250 ↗
• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYELID PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT DEVELOPED A BAD REACTION TO THE SUTURE, AS DIAGNOSED BY AN OPHTHALMOLOGIST. THE PATIENT HAD PROLONGED CHEMOSIS. THE PATIENT WAS TOLD BY THE OPHTHALMOLOGIST THAT THEY HAD AN ALLERGY TO THE SUTURE MATERIAL. THE PATIENT¿S SYMPTOMS RESOLVED AFTER STEROID DROPS AND MEDROL DOSE PACK OVER A FEW MONTHS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 17342249 ↗
• MalfunctionJan 4, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MOHS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES WERE BREAKING AND SUTURE WAS BEING WEAK AND BREAKING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16096166 ↗
• MalfunctionJan 4, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MOHS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES WERE BREAKING AND SUTURE WAS BEING WEAK AND BREAKING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095758 ↗
• MalfunctionJan 4, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MOHS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES WERE BREAKING AND SUTURE WAS BEING WEAK AND BREAKING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095757 ↗
• MalfunctionJan 4, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MOHS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES WERE BREAKING AND SUTURE WAS BEING WEAK AND BREAKING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095756 ↗
• MalfunctionJan 4, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MOHS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES WERE BREAKING AND SUTURE WAS BEING WEAK AND BREAKING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095755 ↗
• MalfunctionDec 7, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. THE NEEDLES WERE BREAKING AND SUTURE WAS BEING WEAK AND BREAKING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15933383 ↗
• MalfunctionDec 7, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. THE NEEDLES WERE BREAKING AND SUTURE WAS BEING WEAK AND BREAKING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15933347 ↗
• MalfunctionOct 27, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ER PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES WERE POPPING OFF THE SUTURE. UNKNOWN AS TO WHAT TYPE OF TISSUE WAS BEING SUTURED DURING THE POP OFF. UNKNOWN AS TO HOW MANY WERE USED DURING THE PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15680281 ↗
• MalfunctionOct 27, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ER PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLES WERE POPPING OFF THE SUTURE. UNKNOWN AS TO WHAT TYPE OF TISSUE WAS BEING SUTURED DURING THE POP OFF. UNKNOWN AS TO HOW MANY WERE USED DURING THE PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15680272 ↗

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.