MONOCRYL Y463GRecalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10705031059252), received between Dec 12, 2017 and Feb 24, 2026 — classified as 50 malfunctions.

The most frequently reported specific device problem is “Material Separation” (23 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE ACCOUNT HAS AN ISSUE WITH THE SUTURE. THE FACILITY HAD ORDERED NINETEEN BOXES AND THE ISSUE IS WITH FOUR (4) BOXES BREAKING DURING MISCLOSURE. THERE WAS NO REPORT OF HARM TO ANYONE. DEVICE AVAILABILITY IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431475 ↗
• MalfunctionFeb 24, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE ACCOUNT HAS AN ISSUE WITH THE SUTURE. THE FACILITY HAD ORDERED NINETEEN BOXES AND THE ISSUE IS WITH FOUR (4) BOXES BREAKING DURING MISCLOSURE. THERE WAS NO REPORT OF HARM TO ANYONE. DEVICE AVAILABILITY IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431474 ↗
• MalfunctionFeb 24, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE ACCOUNT HAS AN ISSUE WITH THE SUTURE. THE FACILITY HAD ORDERED NINETEEN BOXES AND THE ISSUE IS WITH FOUR (4) BOXES BREAKING DURING MISCLOSURE. THERE WAS NO REPORT OF HARM TO ANYONE. DEVICE AVAILABILITY IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431466 ↗
• MalfunctionFeb 24, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE ACCOUNT HAS AN ISSUE WITH THE SUTURE. THE FACILITY HAD ORDERED (B)(4) BOXES AND THE ISSUE IS WITH FOUR (4) BOXES BREAKING DURING MISCLOSURE. THERE WAS NO REPORT OF HARM TO ANYONE. DEVICE AVAILABILITY IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431458 ↗
• MalfunctionJan 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE SUTURE WAS BROKEN EASILY DURING USE. WHEN PUT OUT THREE OR FOUR OF THE SUTURES, THEY WERE IMMEDIATELY BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21172615 ↗
• MalfunctionJan 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE SUTURE WAS BROKEN EASILY DURING USE. WHEN PUT OUT THREE OR FOUR OF THE SUTURES, THEY WERE IMMEDIATELY BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21172592 ↗
• MalfunctionJan 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE SUTURE WAS BROKEN EASILY DURING USE. WHEN PUT OUT THREE OR FOUR OF THE SUTURES, THEY WERE IMMEDIATELY BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21172531 ↗
• MalfunctionJan 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE SUTURE WAS BROKEN EASILY DURING USE. WHEN PUT OUT THREE OR FOUR OF THE SUTURES, THEY WERE IMMEDIATELY BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21172508 ↗
• MalfunctionOct 18, 2024Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN ORAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL, THAT THEY HAD SEVERAL OF THE NEEDLES COME OFF THE SUTURE FROM 1 BOX OF 5/0 MONOCRYL. THEY USED A DIFFERENT BOX TODAY AND DID NOT HAVE ANY ISSUES SO FAR. UNKNOWN IF THE DEVICE WAS RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20483514 ↗
• MalfunctionOct 18, 2024Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN ORAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL, THAT THEY HAD SEVERAL OF THE NEEDLES COME OFF THE SUTURE FROM 1 BOX OF 5/0 MONOCRYL. THEY USED A DIFFERENT BOX TODAY AND DID NOT HAVE ANY ISSUES SO FAR. UNKNOWN IF THE DEVICE WAS RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20483511 ↗
• MalfunctionOct 18, 2024Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN ORAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL, THAT THEY HAD SEVERAL OF THE NEEDLES COME OFF THE SUTURE FROM 1 BOX OF 5/0 MONOCRYL. THEY USED A DIFFERENT BOX TODAY AND DID NOT HAVE ANY ISSUES SO FAR. UNKNOWN IF THE DEVICE WAS RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20483507 ↗
• MalfunctionOct 18, 2024Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN ORAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL, THAT THEY HAD SEVERAL OF THE NEEDLES COME OFF THE SUTURE FROM 1 BOX OF 5/0 MONOCRYL. THEY USED A DIFFERENT BOX TODAY AND DID NOT HAVE ANY ISSUES SO FAR. UNKNOWN IF THE DEVICE WAS RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20483458 ↗
• MalfunctionOct 18, 2024Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN ORAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL, THAT THEY HAD SEVERAL OF THE NEEDLES COME OFF THE SUTURE FROM 1 BOX OF 5/0 MONOCRYL. THEY USED A DIFFERENT BOX TODAY AND DID NOT HAVE ANY ISSUES SO FAR. UNKNOWN IF THE DEVICE WAS RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20483457 ↗
• MalfunctionOct 18, 2024Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN ORAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL, THAT THEY HAD SEVERAL OF THE NEEDLES COME OFF THE SUTURE FROM 1 BOX OF 5/0 MONOCRYL. THEY USED A DIFFERENT BOX TODAY AND DID NOT HAVE ANY ISSUES SO FAR. UNKNOWN IF THE DEVICE WAS RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20483449 ↗
• MalfunctionOct 18, 2024Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN ORAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL, THAT THEY HAD SEVERAL OF THE NEEDLES COME OFF THE SUTURE FROM 1 BOX OF 5/0 MONOCRYL. THEY USED A DIFFERENT BOX TODAY AND DID NOT HAVE ANY ISSUES SO FAR. UNKNOWN IF THE DEVICE WAS RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20483309 ↗
• MalfunctionOct 18, 2024Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN ORAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL, THAT THEY HAD SEVERAL OF THE NEEDLES COME OFF THE SUTURE FROM 1 BOX OF 5/0 MONOCRYL. THEY USED A DIFFERENT BOX TODAY AND DID NOT HAVE ANY ISSUES SO FAR. UNKNOWN IF THE DEVICE WAS RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20483307 ↗
• MalfunctionOct 18, 2024Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN ORAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL, THAT THEY HAD SEVERAL OF THE NEEDLES COME OFF THE SUTURE FROM 1 BOX OF 5/0 MONOCRYL. THEY USED A DIFFERENT BOX TODAY AND DID NOT HAVE ANY ISSUES SO FAR. UNKNOWN IF THE DEVICE WAS RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20483305 ↗
• MalfunctionOct 18, 2024Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN ORAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL, THAT THEY HAD SEVERAL OF THE NEEDLES COME OFF THE SUTURE FROM 1 BOX OF 5/0 MONOCRYL. THEY USED A DIFFERENT BOX TODAY AND DID NOT HAVE ANY ISSUES SO FAR. UNKNOWN IF THE DEVICE WAS RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20483301 ↗
• MalfunctionOct 18, 2024Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN ORAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL, THAT THEY HAD SEVERAL OF THE NEEDLES COME OFF THE SUTURE FROM 1 BOX OF 5/0 MONOCRYL. THEY USED A DIFFERENT BOX TODAY AND DID NOT HAVE ANY ISSUES SO FAR. UNKNOWN IF THE DEVICE WAS RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20483299 ↗
• MalfunctionOct 18, 2024Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN ORAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL, THAT THEY HAD SEVERAL OF THE NEEDLES COME OFF THE SUTURE FROM 1 BOX OF 5/0 MONOCRYL. THEY USED A DIFFERENT BOX TODAY AND DID NOT HAVE ANY ISSUES SO FAR. UNKNOWN IF THE DEVICE WAS RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20483298 ↗
• MalfunctionApr 3, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT PERIODONTAL SURGERY ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. THE SUTURE BROKE ON WHEN TYING THE KNOT AND/OR TIGHTENING THE SUTURE ON THE TISSUE TO BRING TISSUE EDGES TOGETHER. A NEW PACKAGE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19035404 ↗
• MalfunctionApr 2, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT PERIODONTAL SURGERY ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. THE SUTURE BROKE ON WHEN TYING THE KNOT AND/OR TIGHTENING THE SUTURE ON THE TISSUE TO BRING TISSUE EDGES TOGETHER. A NEW PACKAGE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19026017 ↗
• MalfunctionApr 2, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT PERIODONTAL SURGERY ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. THE SUTURE BROKE ON WHEN TYING THE KNOT AND/OR TIGHTENING THE SUTURE ON THE TISSUE TO BRING TISSUE EDGES TOGETHER. A NEW PACKAGE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021944 ↗
• MalfunctionApr 2, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT PERIODONTAL SURGERY ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. THE SUTURE BROKE ON WHEN TYING THE KNOT AND/OR TIGHTENING THE SUTURE ON THE TISSUE TO BRING TISSUE EDGES TOGETHER. A NEW PACKAGE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021733 ↗
• MalfunctionApr 2, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT PERIODONTAL SURGERY ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. THE SUTURE BROKE ON WHEN TYING THE KNOT AND/OR TIGHTENING THE SUTURE ON THE TISSUE TO BRING TISSUE EDGES TOGETHER. A NEW PACKAGE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021545 ↗

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.