MONOCRYL Y303HRecalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10705031058675), received between Apr 10, 2018 and May 13, 2026 — classified as 52 malfunctions.

The most frequently reported specific device problem is “Break” (26 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 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED, WHILE SUTURING, THE SUTURE WAS DETACHED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163957 ↗
• MalfunctionFeb 6, 2026Break; Material Integrity Problem

  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 BROKEN BECAUSE THE SUTURE AT THE PROXIMAL END HAD BEEN DEFORMED. IT WAS NOTICED AFTER USE, BUT THE DOCTOR THINKS THE SUTURE HAD BEEN DEFORMED WHEN THE PACKAGE WAS OPENED. THE SALES REP EXPLAINED THAT THE JOINT BETWEEN THE SUTURE AND THE NEEDLE WAS HOLLOW AND IS PRONE TO BEING DEFORMED IF GRASPED, AND THE DOCTOR SAID THAT THE DOCTOR DID NOT GRASP THAT AREA. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24282575 ↗
• MalfunctionOct 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRIC PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IN THE MONOCRY 5.0 SURGICAL PROCESS, THE INTESTINAL RAFFIA WAS BROKEN, LEAVING THE TIP IN THE PORTAL AND PARTIALLY SUTURED IN THE INTESTINE. THE CHILD SURGEON IMMEDIATELY REALIZED THE SITUATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23311233 ↗
• MalfunctionJul 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINOPLASTY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT, DURING THE VAGINOPLASTY THE NEEDLE OF THE SUTURE KEEPS POOPING OFF. THEY USED ANOTHER SET OF BOXES WITH A DIFFERENT LOT NUMBER. THERE WERE NO PATIENT ADVERSE EVENT. ONE BOX IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509273 ↗
• MalfunctionJul 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINOPLASTY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT, DURING THE VAGINOPLASTY THE NEEDLE OF THE SUTURE KEEPS POOPING OFF. THEY USED ANOTHER SET OF BOXES WITH A DIFFERENT LOT NUMBER. THERE WERE NO PATIENT ADVERSE EVENT. ONE BOX IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509267 ↗
• MalfunctionMay 3, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. DURING THE SURGERY, WHEN SUTURING A FEW STITCHES, THE NEEDLE HAD BEEN DETACHED. IT OCCURRED TWICE IN A ROW. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19238418 ↗
• MalfunctionMay 3, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. DURING THE SURGERY, WHEN SUTURING A FEW STITCHES, THE NEEDLE HAD BEEN DETACHED. IT OCCURRED TWICE IN A ROW. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19238411 ↗
• MalfunctionMar 19, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL PLASTY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP THAT THE NEEDLE BROKE IN HALF DURING A VAGINAL PLASTY PROCEDURE. THEY WERE ABLE TO GET ANOTHER DEVICE TO COMPLETE THE CASE WITHOUT PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18936438 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THEY FOUND THAT THE NEEDLES ARE NOT FIRMLY ATTACHED TO THE SUTURE. THEY HAD SEVERAL PACKAGES NOW WHERE THEY GRAB TISSUE WITH THE NEEDLE, AND GOES TO PULL THROUGH THE SKIN. THE NEEDLES ARE NOT SECURELY ATTACHED TO SUTURE. THEY FALL OFF WHILE IN USE. THERE WAS NO PATIENT CONSEQUENCES. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837396 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THEY FOUND THAT THE NEEDLES ARE NOT FIRMLY ATTACHED TO THE SUTURE. THEY HAD SEVERAL PACKAGES NOW WHERE THEY GRAB TISSUE WITH THE NEEDLE, AND GOES TO PULL THROUGH THE SKIN. THE NEEDLES ARE NOT SECURELY ATTACHED TO SUTURE. THEY FALL OFF WHILE IN USE. THERE WAS NO PATIENT CONSEQUENCES. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837122 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THEY FOUND THAT THE NEEDLES ARE NOT FIRMLY ATTACHED TO THE SUTURE. THEY HAD SEVERAL PACKAGES NOW WHERE THEY GRAB TISSUE WITH THE NEEDLE, AND GOES TO PULL THROUGH THE SKIN. THE NEEDLES ARE NOT SECURELY ATTACHED TO SUTURE. THEY FALL OFF WHILE IN USE. THERE WAS NO PATIENT CONSEQUENCES. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837117 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THEY FOUND THAT THE NEEDLES ARE NOT FIRMLY ATTACHED TO THE SUTURE. THEY HAD SEVERAL PACKAGES NOW WHERE THEY GRAB TISSUE WITH THE NEEDLE, AND GOES TO PULL THROUGH THE SKIN. THE NEEDLES ARE NOT SECURELY ATTACHED TO SUTURE. THEY FALL OFF WHILE IN USE. THERE WAS NO PATIENT CONSEQUENCES. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837113 ↗
• MalfunctionSep 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE. THE NEEDLE WAS REMOVED. THERE WERE NO ADVERSE CONSEQUENCES TO THE ANIMAL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17777074 ↗
• MalfunctionApr 27, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, THE CUSTOMER OPENED NEW PACK TODAY AND FOUND 3 ADDITIONAL 3/0 MONOCRYL SUTURES WITHIN THE 36 PACK OF Y303H 5/0. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16827613 ↗
• MalfunctionApr 6, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691764 ↗
• MalfunctionMar 23, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 2/24/2023 AND SUTURE WAS USED. THE SUTURE BROKE EASILY DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16603898 ↗
• MalfunctionJul 7, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14947781 ↗
• MalfunctionJul 7, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14947773 ↗
• MalfunctionJul 7, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14947770 ↗
• MalfunctionJul 7, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14947755 ↗
• MalfunctionJul 7, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14947708 ↗
• MalfunctionApr 8, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. BEFORE USE ON PATIENT, THE NEEDLE GOT DETACHED FROM THE SUTURE AT THE SWAGE UPON REMOVAL FROM PACKAGING. AFTER INVESTIGATION OF THE RETURNED SAMPLE SHORT INSERTION WAS OBSERVED IN THE STRAND. THE VISUAL INSPECTION CONCLUDED THAT THE COMBINATION OF THE NEEDLE/SUTURE WAS FOUND DETACHED SINCE THE INSERTION END OF THE SUTURE DID NOT MEET THE REQUIREMENT. THE PULL-OUT HAS BEEN CORRELATED TO THE MANUFACTURING PROCESS DUE TO THIS DEFECT IS CAUSED BECAUSE THE SUTURE WAS NOT PROPERLY INSERTED INSIDE OF THE NEEDLE BARREL HOLE RESULTING IN A PULL-OUT DEFECT. NO ADVERSE CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14056439 ↗
• MalfunctionJan 6, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A UNKNOWN FELINE DENTAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE AT FIRST PASS. NEEDLE WAS RECOVERED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13178665 ↗
• MalfunctionJan 6, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A UNKNOWN FELINE DENTAL PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE AT FIRST PASS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13178276 ↗
• MalfunctionOct 19, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPS OFF THE SUTURE MATERIAL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12656312 ↗

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.