MONOCRYL Y399HRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705031059108), received between May 14, 2020 and Sep 18, 2026 — classified as 4 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Material Separation” (8 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Material Separation

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. It was reported that the needle comes loose from the sutures during operation. There were no patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819496 ↗
• MalfunctionSep 18, 2026Material Separation

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. It was reported that the needle comes loose from the sutures during operation. There were no patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819495 ↗
• MalfunctionAug 6, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50166314 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE ON BOTH PRODUCTS DURING THE PROCEDURE. THE TIP OF THE NEEDLE WAS NOT RETRIEVABLE, THEY HAVE A PHOTO ALSO. THERE IS NO ADVERSE IMPACT ON PATIENT/USER REPORTED. DEVICES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451259 ↗
• MalfunctionSep 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. SUTURE SNAPPED WITH MINIMAL FORCE WHILST USING IN C-SECTION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051662 ↗
• MalfunctionSep 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. SUTURE SNAPPED WITH MINIMAL FORCE WHILST USING IN C-SECTION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051657 ↗
• InjuryNov 8, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN MYOMECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE MYOMETRIUM. WHEN MOVING ON TO THE SECOND STITCH AFTER PASSING THE FIRST NEEDLE, THE DOCTOR FOUND THAT THE TIP OF THE NEEDLE HAD BEEN BROKEN. THE NEEDLE WAS ALSO UNUSUALLY BENT. THE BROKEN NEEDLE TIP IS NOT FOUND. THERE IS POSSIBILITY THAT THE PIECE IS LEFT INSIDE THE PATIENT. X-RAY AND CT SCAN WERE INCONCLUSIVE. IT WAS NOT A CONTROL RELEASE NEEDLE. THE PATIENT WAS HOSPITALIZED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20642486 ↗
• MalfunctionFeb 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, TWO OF THE SAME SUTURES SNAPPED WHILE SUTURING CLOSE THE UTERUS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778997 ↗
• MalfunctionFeb 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, TWO OF THE SAME SUTURES SNAPPED WHILE SUTURING CLOSE THE UTERUS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778996 ↗
• MalfunctionFeb 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BECAME DETACHED FROM THE SUTURE IN TWO SEPARATE FOILS. WHEN THE SUTURE WAS PULLED THROUGH THE TISSUE THE NEEDLE CAME AWAY FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18677199 ↗
• MalfunctionFeb 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BECAME DETACHED FROM THE SUTURE IN TWO SEPARATE FOILS. WHEN THE SUTURE WAS PULLED THROUGH THE TISSUE THE NEEDLE CAME AWAY FROM THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18677195 ↗
• MalfunctionFeb 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE HAD BEEN DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16413670 ↗
• MalfunctionJan 14, 2022Material 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 NEEDLE DETACHED FROM THE SUTURE WHILE SUTURING THE MYOMETRIUM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13257538 ↗
• MalfunctionOct 12, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FRAYED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12619181 ↗
• InjuryMar 19, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. ONE DAY POST-OP, THE INCISION HAD DEHISCED, AND THE PATIENT'S BOWELS WERE COMING OUT. THE PATIENT WAS RUSHED TO OPERATING ROOM WHERE THE SURGEON BELIEVED THAT THE SUTURE FAILED AT THE MIDLINE OF THE INCISION. THE PATIENT DOING FINE AND WAS DISCHARGED (B)(6) 2021. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 11530082 ↗
• MalfunctionAug 11, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BECAME DETACHED FROM SUTURE THREAD DURING ROUTINE CLOSURE FOR C-SECTION. SUTURE WAS NOT UNDER HIGH TENSION DURING USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10392763 ↗
• InjuryMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION PROCEDURE IN 2020 AND THE SUTURE WAS USED ON UTERUS. THE PATIENT RETURNED FOUR WEEKS POST OP COMPLAINING OF PAIN. INITIALLY THE PATIENT WAS PROVIDED WITH ORAL ANTIBIOTICS HOWEVER PAIN DID NOT SUBSIDE. IT WAS ALSO NOTICED SOME CELLULITIS AND THEREAFTER A SURGEON DECIDED TO RE-OPEN. PRESENCE OF PUSS WAS FOUND ON RECTUS SHEATH. THE WASHED OUT PROCEDURE WAS PERFORMED AND A SECONDARY SUTURE PLACED. THE SURGEON IS UNSURE WHETHER EVENT IS SUTURE RELATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Cellulitis; Not Applicable; Pain; Post Operative Wound Infection; Purulent Discharge

  MAUDE report 10058178 ↗
• InjuryMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C-SECTION PROCEDURE IN 2020 AND THE SUTURE WAS USED ON UTERUS. THE PATIENT RETURNED FOUR WEEKS POST OP COMPLAINING OF PAIN. INITIALLY THE PATIENT WAS PROVIDED WITH ORAL ANTIBIOTICS HOWEVER PAIN DID NOT SUBSIDE. IT WAS ALSO NOTICED SOME CELLULITIS AND THEREAFTER A SURGEON DECIDED TO RE-OPEN. PRESENCE OF PUSS WAS FOUND ON RECTUS SHEATH. THE WASHED OUT PROCEDURE WAS PERFORMED AND A SECONDARY SUTURE PLACED. THE SURGEON IS UNSURE WHETHER EVENT IS SUTURE RELATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Cellulitis; Not Applicable; Pain; Post Operative Wound Infection; Purulent Discharge

  MAUDE report 10057818 ↗

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.