MONOCRYL Y943GRecalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 10705031218635), received between Dec 20, 2017 and May 6, 2026 — classified as 77 malfunctions.

The most frequently reported specific device problem is “Break” (49 reports).

2 other recalls cover devices cleared under the same FDA submission (K960653); 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 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Material Frayed

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL, PER HEALTHCARE PROFESSIONAL THAT THE PRODUCT WAS FRAYING AND COMING APART FOR 3 DIFFERENT PATIENTS AND 3 DIFFERENT DOCTORS. 2 PATIENTS HAD THE WOUNDS COME OPEN 1 PATIENT NEED ER CARE. ONE PATIENT IS RETURNING. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 25092995 ↗
• MalfunctionJan 6, 2026Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE CAME OFF OF THE SUTURE WHILE THE SURGEON WAS CLOSING A SPAY PATIENT DURING A VET SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23980623 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE NEEDLE CAME OFF OF THE SUTURE WHILE DOCTOR WAS CLOSING A SPAY PATIENT ON 9/11. NO PATIENT CONSEQUENCE IS REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23286506 ↗
• MalfunctionSep 29, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. POST-OP, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT, AFTER THE SURGERY THE DOG EXPERIENCE INTERNAL BLEEDING AND UPON OPENING THE INCISION THE SUTURE WAS DISSOLVED. THE DOG WAS STABLE AND WAS SENT TO EMERGENCY ROOM. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23169164 ↗
• MalfunctionJul 15, 2025Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THEY HAVE MANY DEHISCENCE, DURING AN UNKNOWN PROCEDURE, SOME OF THE SUTURES BROKE OFF AND SOME OF THEM WERE FRAYED. NO ADVERSE EVENT WAS REPORTED. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22515529 ↗
• MalfunctionJul 15, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THEY HAVE MANY DEHISCENCE, DURING AN UNKNOWN PROCEDURE, SOME OF THE SUTURES BROKE OFF AND SOME OF THEM WERE FRAYED. NO ADVERSE EVENT WAS REPORTED. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22515524 ↗
• MalfunctionJul 15, 2025Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THEY HAVE MANY DEHISCENCE, DURING AN UNKNOWN PROCEDURE, SOME OF THE SUTURES BROKE OFF AND SOME OF THEM WERE FRAYED. NO ADVERSE EVENT WAS REPORTED. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22515520 ↗
• MalfunctionJul 15, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THEY HAVE MANY DEHISCENCE, DURING AN UNKNOWN PROCEDURE, SOME OF THE SUTURES BROKE OFF AND SOME OF THEM WERE FRAYED. NO ADVERSE EVENT WAS REPORTED. DEVICES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22515518 ↗
• MalfunctionApr 2, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN ANIMAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE INTERRUPTED SUTURES HAD 80% OF THESE SUTURES FRAYED AND NO LONGER INTACT OR HOLDING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21752172 ↗
• MalfunctionApr 2, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN ANIMAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE INTERRUPTED SUTURES HAD 80% OF THESE SUTURES FRAYED AND NO LONGER INTACT OR HOLDING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21752171 ↗
• MalfunctionApr 2, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE INTERRUPTED SUTURES THAT APPEARED NOT TO HOLD AND FRAYED. ONLY 1 OR 2 WAS INTACT WITH SOME FRAYING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21752169 ↗
• MalfunctionFeb 4, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21308699 ↗
• MalfunctionFeb 4, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21308168 ↗
• MalfunctionFeb 4, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307894 ↗
• MalfunctionFeb 3, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21292815 ↗
• MalfunctionJan 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE SUTURE WAS COMING OFF OF NEEDLE UPON USE. THERE WERE NO PATIENT CONSEQUENCE WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21130384 ↗
• MalfunctionSep 10, 2024Material 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 NEEDLE FELL OFF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181871 ↗
• MalfunctionSep 10, 2024Material 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 NEEDLE FELL OFF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181866 ↗
• MalfunctionMay 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE WAS FALLING OFF THE SUTURE WITH LITTLE TENSION/EFFORT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281088 ↗
• MalfunctionApr 1, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ANIMAL PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, THREE STRANDS FROM ONE BOX, THE NEEDLE CAME UNSWAGED. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014816 ↗
• MalfunctionApr 1, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ANIMAL PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, THREE STRANDS FROM ONE BOX, THE NEEDLE CAME UNSWAGED. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014770 ↗
• MalfunctionApr 1, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ANIMAL PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, THREE STRANDS FROM ONE BOX, THE NEEDLE CAME UNSWAGED. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014756 ↗
• MalfunctionDec 5, 2023Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT A SPAYING & NEUTERING PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. POST-OP T WAS REPORTED BY ACCOUNT CONTACT: ¿DURING A FELINE SPRAY PROCEDURE THE SUTURE DID NOT HOLD BODY WALL OPENED/HERNIATED WITHIN 24 HOURS OF SURGERY.¿ IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 18271667 ↗
• MalfunctionDec 5, 2023Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT A SPAYING & NEUTERING PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. POST-OP, IT WAS REPORTED BY ACCOUNT CONTACT: ¿DURING A CANINE SPRAY PROCEDURE THE SUTURE IN THE BODY WALL DID NOT HOLD COMPLETELY PATIENT DEVELOPED A HERNIA REQUIRING A SECOND SURGERY TO REPAIR.¿ IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia

  MAUDE report 18271666 ↗
• MalfunctionOct 31, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE OR BEFORE USE ON THE PATIENT, IT WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER THAT DURING AN UNKNOWN PROCEDURE, SUTURE IS BREAKING BEFORE TYING OFF. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18044234 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K960653. One submission often covers many models, so check the product and lot details in each record.

• Z-2148-2024 · May 10, 2024 · Open, Classified
  MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345
• Z-1311-2009 · Feb 2, 2009 · Terminated
  MONOCRYL (poliglecaprone 25 ) Suture, Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and/or ligation.