MONOCRYL Y464GRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10705031059269), received between Mar 5, 2018 and May 11, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Material Separation” (17 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. 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY SALES REP THAT ACCOUNT HAD MULTIPLE INCIDENTS WHERE THE NEEDLES WERE FALLING OFF OF THE MONOCRYL 2-0 AND 4-0 AND PDS THEY ARE ORDERING. THIS HAPPENED WITH VARIOUS LOT NUMBER OVER A PERIOD OF ABOUT A YEAR. THEY WERE UNABLE TO RECORD THE LOT NUMBERS OF THE AFFECTED PRODUCTS AT THE TIME. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE AVAILABILITY IS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136512 ↗
• MalfunctionNov 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLES BROKE OFF DURING SURGERY. NO PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20783547 ↗
• MalfunctionSep 19, 2024Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE ENTIRE SUTURE SITE HAD DEHISCED, AND IT SEEMS THAT THE SUTURE WAS DEGRADING IN 1-2 DAYS.

  Patient problems: Wound Dehiscence

  MAUDE report 20262441 ↗
• MalfunctionSep 19, 2024Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE ENTIRE SUTURE SITE HAD DEHISCED, AND IT SEEMS THAT THE SUTURE WAS DEGRADING IN 1-2 DAYS.

  Patient problems: Wound Dehiscence

  MAUDE report 20262161 ↗
• MalfunctionJun 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE THREAD DETACHED FROM THE NEEDLE DURING SURGERY AND EVEN WHEN PULLING OUT OF THE PACK. NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19625393 ↗
• MalfunctionJun 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE THREAD DETACHED FROM THE NEEDLE DURING SURGERY AND EVEN WHEN PULLING OUT OF THE PACK. NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19625387 ↗
• MalfunctionJun 26, 2023Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE GOT DETACHED FROM A MONOCRYL SUTURE DURING A DOG NEUTER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17202248 ↗
• MalfunctionJun 26, 2023Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE GOT DETACHED FROM A MONOCRYL SUTURE DURING A DOG NEUTER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17202141 ↗
• MalfunctionJun 26, 2023Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT THEY HAD HAD TWO PROCEDURES TODAY IN WHICH THE NEEDLE HAS FALLEN OFF THE SUTURE MATERIAL IN THE OPERATING SITES. NO PRODUCT WAS NOTED BEING AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199977 ↗
• MalfunctionJun 26, 2023Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT THEY HAD HAD TWO PROCEDURES TODAY IN WHICH THE NEEDLE HAS FALLEN OFF THE SUTURE MATERIAL IN THE OPERATING SITES. NO PRODUCT WAS NOTED BEING AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199975 ↗
• MalfunctionAug 24, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A QUADRANTECTOMY AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS FOUND THAT THE NEEDLE WAS DETACHED FROM THE SUTURE BEFORE USE. IT WAS NOT A CONTROL RELEASE NEEDLE. UPON EVALUATION OF THE DEVICE, THE SUTURE HAS BEGUN WITH PROCESS DEGRADATION CAUSED BY EXPOSURE TO THE ENVIRONMENT AND THE NEEDLE DETACHED FROM THE STRAND. AS THE SAMPLE WAS RECEIVED OPEN, THE TIME OF EXPOSURE TO THE ENVIRONMENT COULD NOT BE DETERMINED AND FUNCTIONAL TESTS CANNOT BE PERFORMED. THE FOIL PACKET WAS VISUALLY INSPECTED, AND EXCESSIVE WRINKLES, DELAMINATION, AND HOLES IN THE CAVITY WERE OBSERVED. THIS CONDITION CONTRIBUTED TO THE DEGRADATION OF THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15289267 ↗
• MalfunctionJan 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING USE ON THE PATIENT IT WAS NOTED THAT THE NEEDLE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13256187 ↗
• MalfunctionNov 18, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION SURGERY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12839062 ↗
• MalfunctionAug 17, 2021Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. WHEN THE SURGEON TRIED TO SUTURE, IT WAS FOUND THAT THE NEEDLE HAD BEEN CHIPPED FROM THE BEGINNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12333368 ↗
• MalfunctionSep 14, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN STOMA CLOSURE PROCEDURE ON AN UNKNOWN DATE; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE PULLING THE FIRST STITCH. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10531057 ↗
• MalfunctionFeb 25, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS FOUND THAT THE SUTURE HAD BEEN DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9749696 ↗
• MalfunctionDec 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN TRYING TO USE THE NEEDLE-SUTURE, THE SUTURE WAS DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9412203 ↗
• MalfunctionDec 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN TRYING TO USE THE NEEDLE-SUTURE, THE SUTURE WAS DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9412201 ↗
• MalfunctionDec 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN TRYING TO USE THE NEEDLE-SUTURE, THE SUTURE WAS DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9412167 ↗
• MalfunctionMar 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A DENTAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED FOR SUTURING THE EXTRACTION SITE. DURING THE PROCEDURE, WHEN CLAMPING ON NEEDLE AND TAKING A BITE OF TISSUE, THE NEEDLE PULLED COMPLETELY OFF THE SUTURE. IT APPEARED TO BE WHERE THE SUTURE IS SWEDGED ON TO THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8386616 ↗
• MalfunctionMar 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A DENTAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED FOR SUTURING THE EXTRACTION SITE. DURING THE PROCEDURE, WHEN CLAMPING ON NEEDLE AND TAKING A BITE OF TISSUE, THE NEEDLE PULLED COMPLETELY OFF THE SUTURE. IT APPEARED TO BE WHERE THE SUTURE IS SWEDGED ON TO THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8386615 ↗
• MalfunctionMar 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A DENTAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED FOR SUTURING THE EXTRACTION SITE. DURING THE PROCEDURE, WHEN CLAMPING ON NEEDLE AND TAKING A BITE OF TISSUE, THE NEEDLE PULLED COMPLETELY OFF THE SUTURE. IT APPEARED TO BE WHERE THE SUTURE IS SWEDGED ON TO THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8386613 ↗
• MalfunctionMar 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A DENTAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED FOR SUTURING THE EXTRACTION SITE. DURING THE PROCEDURE, WHEN CLAMPING ON NEEDLE AND TAKING A BITE OF TISSUE, THE NEEDLE PULLED COMPLETELY OFF THE SUTURE. IT APPEARED TO BE WHERE THE SUTURE IS SWEDGED ON TO THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8386612 ↗
• MalfunctionMay 17, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A DENTAL PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE POPPED OFF THE NEEDLE DURING A SIMPLE INTERRUPTED SUTURE LINE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE ANIMAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7524694 ↗
• MalfunctionMar 5, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE WHILE CLOSING THE SURGICAL WOUND UNDER THE SKIN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7313573 ↗

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.