ETHILON F2440HRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031239043), received between Aug 2, 2019 and Feb 13, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Separation” (13 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2024Material 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 THAT IN ONE BOX OF SUTURES, THE NEEDLE PULLED OFF ON A GOOD PART OF THE BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696617 ↗
• MalfunctionFeb 13, 2024Material 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 THAT IN ONE BOX OF SUTURES, THE NEEDLE PULLED OFF ON A GOOD PART OF THE BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696614 ↗
• MalfunctionFeb 13, 2024Material 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 THAT IN ONE BOX OF SUTURES, THE NEEDLE PULLED OFF ON A GOOD PART OF THE BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696611 ↗
• MalfunctionFeb 13, 2024Material 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 THAT IN ONE BOX OF SUTURES, THE NEEDLE PULLED OFF ON A GOOD PART OF THE BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696610 ↗
• MalfunctionFeb 13, 2024Material 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 THAT IN ONE BOX OF SUTURES, THE NEEDLE PULLED OFF ON A GOOD PART OF THE BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696609 ↗
• MalfunctionFeb 13, 2024Material 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 THAT IN ONE BOX OF SUTURES, THE NEEDLE PULLED OFF ON A GOOD PART OF THE BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696608 ↗
• MalfunctionFeb 13, 2024Material 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 THAT IN ONE BOX OF SUTURES, THE NEEDLE PULLED OFF ON A GOOD PART OF THE BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696606 ↗
• MalfunctionFeb 13, 2024Material 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 THAT IN ONE BOX OF SUTURES, THE NEEDLE PULLED OFF ON A GOOD PART OF THE BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696604 ↗
• MalfunctionFeb 13, 2024Material 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 THAT IN ONE BOX OF SUTURES, THE NEEDLE PULLED OFF ON A GOOD PART OF THE BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696603 ↗
• MalfunctionFeb 13, 2024Material 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 THAT IN ONE BOX OF SUTURES, THE NEEDLE PULLED OFF ON A GOOD PART OF THE BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696601 ↗
• MalfunctionJun 8, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A VETERINARY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SUTURING THE JOINT CAPSULE OF THE KNEE, AFTER A FEW PASSAGES THROUGH THE TISSUE AND WITHOUT EXERTING EXCESSIVE PRESSURE, THE NEEDLE PULLED OFF FROM THE THREAD. ANOTHER UNIT FROM THE SAME LOT WAS USED: THE NEEDLE PULLED OFF UNDER THE SAME CONDITIONS, AFTER A FEW PASSAGES THROUGH THE JOINT CAPSULE. THE SURGERY WAS COMPLETED, USING A NEW THREAD, WITHOUT AFFECTING THE ANIMAL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17086291 ↗
• MalfunctionJun 8, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A VETERINARY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SUTURING THE JOINT CAPSULE OF THE KNEE, AFTER A FEW PASSAGES THROUGH THE TISSUE AND WITHOUT EXERTING EXCESSIVE PRESSURE, THE TIP OF THE NEEDLE BROKE. IT COULD BE RECOVERED AND WAS NOT "LOST" IN THE DOG'S JOINT. THE SURGERY WAS COMPLETED, USING A NEW THREAD, WITHOUT AFFECTING THE ANIMAL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17086288 ↗
• MalfunctionJun 8, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A VETERINARY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN SUTURING THE JOINT CAPSULE OF THE KNEE, AFTER A FEW PASSAGES THROUGH THE TISSUE AND WITHOUT EXERTING EXCESSIVE PRESSURE, THE NEEDLE PULLED OFF FROM THE THREAD. ANOTHER UNIT FROM THE SAME LOT WAS USED: THE NEEDLE PULLED OFF UNDER THE SAME CONDITIONS, AFTER A FEW PASSAGES THROUGH THE JOINT CAPSULE. THE SURGERY WAS COMPLETED, USING A NEW THREAD, WITHOUT AFFECTING THE ANIMAL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17086286 ↗
• MalfunctionAug 2, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROLAPSE PROCEDURE ON UNKNOWN DATE IN 2019 AND SUTURE WAS USED. WHEN THE SURGEON PASSED THE THREAD THROUGH THE LEVATOR ANI MUSCLE, THE NEEDLE TOOK OFF THE STRAND. THE NEEDLE STAYED INSIDE THE PATIENT'S MUSCLE. AFTER ATTEMPTING TO RETRIEVE THE NEEDLE, AN INTENSIFYING RADIO WAS PERFORMED BUT THE SURGEON COULD NOT REMOVE THE NEEDLE FROM THE PATIENT. AN ULTRASOUND EXAMINATION (WITH A DEVICE FROM THE MATERNITY UNIT) WAS PERFORMED BUT THE SURGEON COULD NOT SEE THE NEEDLE. THERE ARE NO PLANS TO REMOVE THE NEEDLE AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8856672 ↗

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.