MONOCRYL Y304HRecalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 10705031058699), received between Dec 4, 2018 and May 19, 2026 — classified as 1 injury, 67 malfunctions.

The most frequently reported specific device problem is “Break” (34 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 68 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Break

  IT WAS REPORTED AN ANIMAL UNDERWENT A SPAY VETERINARY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. POST-OP, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT DURING SPAY PROCEDURE, INCISION DEHISCENCE OCCURRED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 25221843 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT A RECURRING FAILURE HAS BEEN IDENTIFIED IN THE MEDICAL DEVICE MONOCRYL¿ SYNTHETIC ABSORBABLE SUTURE, USED IN SURGICAL PROCEDURES TO APPROXIMATE OR LIGATE SOFT TISSUES. THE DETECTED FAILURE MANIFESTS AS A WEAKNESS IN THE NEEDLE MATERIAL, CAUSING IT TO BREAK UPON FIRST CONTACT WITH THE SKIN. THIS DEFECT COMPROMISES THE FUNCTIONALITY OF THE DEVICE AND PUTS THE SAFETY OF THE SURGICAL PROCEDURE AT RISK, SINCE THE NEEDLE DOES NOT PERFORM ITS FUNCTION PROPERLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292590 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT A RECURRING FAILURE HAS BEEN IDENTIFIED IN THE MEDICAL DEVICE MONOCRYL¿ SYNTHETIC ABSORBABLE SUTURE, USED IN SURGICAL PROCEDURES TO APPROXIMATE OR LIGATE SOFT TISSUES. THE DETECTED FAILURE MANIFESTS AS A WEAKNESS IN THE NEEDLE MATERIAL, CAUSING IT TO BREAK UPON FIRST CONTACT WITH THE SKIN. THIS DEFECT COMPROMISES THE FUNCTIONALITY OF THE DEVICE AND PUTS THE SAFETY OF THE SURGICAL PROCEDURE AT RISK, SINCE THE NEEDLE DOES NOT PERFORM ITS FUNCTION PROPERLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291835 ↗
• MalfunctionJun 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT THE SUTURE WAS BREAKING AT THE TAIL. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320491 ↗
• MalfunctionMay 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE PRODUCT PRESENTED PROBLEMS. THE DETECTION OF RECURRENT FAILURE IN THE SYNTHETIC ABSORBABLE SUTURE MEDICAL DEVICE, USED IN SURGICAL PROCEDURES TO APPROXIMATE OR BIND SOFT TISSUES, IS REPORTED. THE IDENTIFIED FAULT CORRESPONDS TO A WEAKNESS IN THE MATERIAL, MANIFESTED AS FOLLOWS: AT FIRST CONTACT WITH THE SKIN, THE NEEDLE BREAKS, COMPROMISING ITS FUNCTIONALITY. THIS SITUATION AFFECTS THE SAFETY OF THE SURGICAL PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21979583 ↗
• MalfunctionMay 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE PRODUCT PRESENTED PROBLEMS. THE DETECTION OF RECURRENT FAILURE IN THE SYNTHETIC ABSORBABLE SUTURE MEDICAL DEVICE, USED IN SURGICAL PROCEDURES TO APPROXIMATE OR BIND SOFT TISSUES, IS REPORTED. THE IDENTIFIED FAULT CORRESPONDS TO A WEAKNESS IN THE MATERIAL, MANIFESTED AS FOLLOWS: AT FIRST CONTACT WITH THE SKIN, THE NEEDLE BREAKS, COMPROMISING ITS FUNCTIONALITY. THIS SITUATION AFFECTS THE SAFETY OF THE SURGICAL PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21979573 ↗
• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN ATTEMPTING TO TIE OFF (WHEN BEING PULLED TO TIE A KNOT). NO ADVERSE CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21768096 ↗
• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN ATTEMPTING TO TIE OFF (WHEN BEING PULLED TO TIE A KNOT). NO ADVERSE CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21768084 ↗
• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN ATTEMPTING TO TIE OFF (WHEN BEING PULLED TO TIE A KNOT). NO ADVERSE CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21768083 ↗
• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN ATTEMPTING TO TIE OFF (WHEN BEING PULLED TO TIE A KNOT). NO ADVERSE CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21768075 ↗
• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN ATTEMPTING TO TIE OFF (WHEN BEING PULLED TO TIE A KNOT). NO ADVERSE CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21768068 ↗
• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN ATTEMPTING TO TIE OFF (WHEN BEING PULLED TO TIE A KNOT). NO ADVERSE CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21768064 ↗
• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN ATTEMPTING TO TIE OFF (WHEN BEING PULLED TO TIE A KNOT). NO ADVERSE CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21768057 ↗
• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN ATTEMPTING TO TIE OFF (WHEN BEING PULLED TO TIE A KNOT). NO ADVERSE CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21768051 ↗
• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN ATTEMPTING TO TIE OFF (WHEN BEING PULLED TO TIE A KNOT). NO ADVERSE CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21768049 ↗
• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN ATTEMPTING TO TIE OFF (WHEN BEING PULLED TO TIE A KNOT). NO ADVERSE CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21768045 ↗
• MalfunctionDec 5, 2024Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER CUSTOMER: "THE CLINIC REPORTS THAT THE SUTURE NEEDLE IS COMING OFF OF THE SUTURE." THERE WAS NO PATIENT CONSEQUENCES. THE 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 20858506 ↗
• MalfunctionJul 23, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CUSTOMER REPORTED A PACK OF SUTURE WAS OPENED AND FOUND WITH A FOREIGN BODY INSIDE THE STERILE PACKAGING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19808705 ↗
• MalfunctionJul 19, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, THE SUTURE PACK WAS OPENED AND A FOREIGN OBJECT FELL OUT OF THE PACKET. CASE WAS COMPLETED WITH A LIKE DEVICE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19784153 ↗
• MalfunctionFeb 29, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INFLAMMATORY BOWEL DISEASE PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. THE NEEDLE DETACHED FROM THE SUTURE DURING GASTROINTESTINAL ANASTOMOSIS. SUTURE METHOD WAS CONTINUOUS SUTURE AND THE PRODUCT WAS USED ON DIGESTIVE TRACT. THE SURGEON DID NOT PULL THE SUTURE EXCESSIVELY. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18809356 ↗
• InjuryMay 16, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN GYNECOLOGICAL SURGERY OVER A YEAR AGO ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN AND LEFT INSIDE THE BODY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16940004 ↗
• MalfunctionDec 21, 2022Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. DURING PROCEDURE, THE NEEDLE IS COMING OUT OF SUTURE WHEN PULL ON IT. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ONE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16028857 ↗
• MalfunctionDec 21, 2022Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING PROCEDURE, THE NEEDLE IS COMING OUT OF SUTURE WHEN PULL ON IT. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ONE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16028748 ↗
• MalfunctionDec 21, 2022Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. DURING PROCEDURE, THE NEEDLE IS COMING OUT OF SUTURE WHEN PULL ON IT. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ONE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16028713 ↗
• MalfunctionDec 21, 2022Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. DURING PROCEDURE, THE NEEDLE IS COMING OUT OF SUTURE WHEN PULL ON IT. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ONE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16028695 ↗

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.