MONOCRYL Y967HRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031059993), received between Dec 13, 2018 and Apr 24, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT DEVELOPED A RESISTANT BACTERIA INFECTION ON THE TOP SKIN LAYER. THE BOX WAS THROWN AWAY SO NO PRODUCT, BATCH OR SERIAL NUMBER IS AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 24987826 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED AN ANIMAL PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE AND SUTURE WAS USED. THE MATERIAL STARTED SPLITTING. THEY HAD TO GRAB A NEW ONE. NO ADVERSE IMPACT PATIENT/USER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387607 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED AN ANIMAL PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE AND SUTURE WAS USED. THE MATERIAL STARTED SPLITTING. THEY HAD TO GRAB A NEW ONE. NO ADVERSE IMPACT PATIENT/USER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24387605 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE AND POPPED WHERE THEY PLACED IT AND THE ANIMAL DEVELOPED A HERNIA. NO FURTHER INFORMATION PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia; Pocket Erosion

  MAUDE report 22897222 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE AND POPPED WHERE THEY PLACED IT AND THE ANIMAL DEVELOPED A HERNIA. NO FURTHER INFORMATION PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia; Pocket Erosion

  MAUDE report 22897194 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE AND POPPED WHERE THEY PLACED IT AND THE ANIMAL DEVELOPED A HERNIA. NO FURTHER INFORMATION PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia; Pocket Erosion

  MAUDE report 22897134 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE AND POPPED WHERE THEY PLACED IT AND THE ANIMAL DEVELOPED A HERNIA. NO FURTHER INFORMATION PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia; Pocket Erosion

  MAUDE report 22897115 ↗
• MalfunctionSep 6, 2024Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE NEEDLE FELL OFF THE SUTURE. DEVICE WAS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20161564 ↗
• MalfunctionDec 19, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPAY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE PACKAGE WAS OPENED, THE NEEDLE WAS NOT ATTACHED TO THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. UPON EVALUATION OF THE RETURNED DEVICE, SHORT INSERTION WAS FOUND. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16008653 ↗
• MalfunctionNov 20, 2019Break; Break

  IT WAS REPORTED BY VET THAT THE ANIMAL UNDERWENT AN ANIMAL C-SECTION SURGERY ON (B)(6) 2019 AND THE SUTURE WAS USED ON THE ABDOMINAL WALL OF THE CANINE, USING AN INTERRUPTED LOOP. ON (B)(6) 2019, THE SUTURE FOUND TO BE BROKEN 2/3 WAY OF CONTINUOUS LINE; KNOTS WERE INTACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9349468 ↗
• MalfunctionDec 13, 2018Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPAY PROCEDURE ON (B)(6) 2018 AND A SUTURE WAS USED. DURING SURGERY, THE DOCTOR NOTICED THAT EVERY TIME HE TRIED TO TIE THE SUTURE THE SUTURE WOULD BREAK WITH LITTLE TO NO PRESSURE. WHEN HE WOULD GO TO TIGHTEN THE KNOT ON THE SUTURE IT WOULD BREAK, THE SUTURE WAS VERY BRITTLE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8161822 ↗

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.