MONOCRYL Y923HRecalls & reported problems

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 10705031059863), received between Apr 10, 2018 and Mar 18, 2026 — classified as 4 injuries, 107 malfunctions.

The most frequently reported specific device problem is “Break” (77 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 111 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THE CURRENT BOX OF SUTURE HAS HAD MANY PROBLEMS WITH BREAKAGE AND FRAYING. THERE HAVE BEEN 8 PACKS THAT HAVE HAD THIS PROBLEM. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634224 ↗
• MalfunctionMar 18, 2026Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THE CURRENT BOX OF SUTURE HAS HAD MANY PROBLEMS WITH BREAKAGE AND FRAYING. THERE HAVE BEEN 8 PACKS THAT HAVE HAD THIS PROBLEM. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634218 ↗
• MalfunctionMar 18, 2026Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THE CURRENT BOX OF SUTURE HAS HAD MANY PROBLEMS WITH BREAKAGE AND FRAYING. THERE HAVE BEEN 8 PACKS THAT HAVE HAD THIS PROBLEM. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630557 ↗
• MalfunctionMar 18, 2026Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THE CURRENT BOX OF SUTURE HAS HAD MANY PROBLEMS WITH BREAKAGE AND FRAYING. THERE HAVE BEEN 8 PACKS THAT HAVE HAD THIS PROBLEM. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628174 ↗
• MalfunctionMar 18, 2026Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THE CURRENT BOX OF SUTURE HAS HAD MANY PROBLEMS WITH BREAKAGE AND FRAYING. THERE HAVE BEEN 8 PACKS THAT HAVE HAD THIS PROBLEM. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628128 ↗
• MalfunctionMar 18, 2026Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THE CURRENT BOX OF SUTURE HAS HAD MANY PROBLEMS WITH BREAKAGE AND FRAYING. THERE HAVE BEEN 8 PACKS THAT HAVE HAD THIS PROBLEM. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628125 ↗
• MalfunctionMar 18, 2026Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THE CURRENT BOX OF SUTURE HAS HAD MANY PROBLEMS WITH BREAKAGE AND FRAYING. THERE HAVE BEEN 8 PACKS THAT HAVE HAD THIS PROBLEM. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628117 ↗
• MalfunctionMar 18, 2026Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THE CURRENT BOX OF SUTURE HAS HAD MANY PROBLEMS WITH BREAKAGE AND FRAYING. THERE HAVE BEEN 8 PACKS THAT HAVE HAD THIS PROBLEM. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628112 ↗
• MalfunctionJan 12, 2026Break; Positioning Failure

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT, THE CLINIC REPORTS ISSUES WITH THE SUTURE KEPT BREAKING WHILE IN PROCEDURE, THEY ALSO HAD PATIENT RE-PRESENT WITH THE SUTURE HAVING COME UNTIED. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037446 ↗
• MalfunctionJan 12, 2026Break; Positioning Failure

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT, THE CLINIC REPORTS ISSUES WITH THE SUTURE KEPT BREAKING WHILE IN PROCEDURE, THEY ALSO HAD PATIENT RE-PRESENT WITH THE SUTURE HAVING COME UNTIED. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036844 ↗
• MalfunctionJan 12, 2026Break; Positioning Failure

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT, THE CLINIC REPORTS ISSUES WITH THE SUTURE KEPT BREAKING WHILE IN PROCEDURE, THEY ALSO HAD PATIENT RE-PRESENT WITH THE SUTURE HAVING COME UNTIED. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036505 ↗
• MalfunctionNov 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANIMAL SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE DVM ATTEMPTED TO USE THE PRODUCT DURING SURGERY BUT THE ITEM BROKE OFF AND FELL INTO THE PATIENT. THE DVM WAS ABLE TO FIND THE PRODUCT. 0.1CM OF THE NEEDLE REMAINING CONNECTED TO THE THREAD. THE REST OF THE NEEDLE BROKE OFF. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633238 ↗
• MalfunctionJul 24, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A OVARIOHYSTERECTOMY (OVH) PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT SUTURE BREAKING AT TAIL END OF SUTURE WHEN TIE KNOTS BEFORE CUTTING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587739 ↗
• MalfunctionJun 20, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT DOCTOR WENT TO USE SUTURE AND IT KEEPS BREAKING IN THE MIDDLE. DOCTOR IS NOT ABLE TO WORK ON SURGERY. DEVICE AVAILABILITY UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298353 ↗
• MalfunctionJun 20, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT DOCTOR WENT TO USE SUTURE AND IT KEEPS BREAKING IN THE MIDDLE. DOCTOR IS NOT ABLE TO WORK ON SURGERY. DEVICE AVAILABILITY UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298352 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 CAME BACK WITH AN OPEN WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21070323 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 CAME BACK WITH AN OPEN WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21070321 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 CAME BACK WITH AN OPEN WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21070320 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 CAME BACK WITH AN OPEN WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21070315 ↗
• MalfunctionOct 17, 2024Break; Product Quality Problem; Break; Product Quality Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UN KNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED IT WAS BREAKING AND UNTYING. THERE WAS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471981 ↗
• MalfunctionJul 9, 2024Break; Product Quality Problem; Break; Product Quality Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ANIMAL SPAY PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. DURING SUTURING A DOG AFTER A SPAY PROCEDURE, KNOTS WERE COMING UNDONE AND SNAPPING TOO EASILY; FEELS DIFFERENT THAN OTHER LOT CODES. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19703268 ↗
• MalfunctionMar 28, 2024Break; Break

  IT WAS REPORTED THAT A FELINE UNDERWENT A SPAY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. POSTOPERATIVELY, THE PATIENT NEEDED TO BE RE-SUTURED DUE TO THE INCISION SITE OPENING UP ABOUT THIRTY MINUTES AFTER SURGERY. PATIENT WAS REPORTED TO BE DOING WELL OVERALL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Wound Dehiscence

  MAUDE report 18998254 ↗
• MalfunctionMar 28, 2024Break; Break

  IT WAS REPORTED THAT A CANINE UNDERWENT A TOOTH EXTRACTION ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE WHILE TYING THE KNOT WHILE CLOSING THE GUMS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18996710 ↗
• MalfunctionMar 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY SURGERY ON AN UNKNOWN DATE, AND SUTURE WAS USED. IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT THEY HAVE HAD PROBLEMS WITH THE NEEDLE ON CURRENT BOX OF 3-0 MONOCRYL COMING OFF THE SUTURE DURING THE FIRST SEVERAL STITCHES - IT HAS HAPPENED 3 TIMES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967717 ↗
• MalfunctionMar 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY SURGERY ON AN UNKNOWN DATE, AND SUTURE WAS USED. IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT THEY HAVE HAD PROBLEMS WITH THE NEEDLE ON CURRENT BOX OF 3-0 MONOCRYL COMING OFF THE SUTURE DURING THE FIRST SEVERAL STITCHES - IT HAS HAPPENED 3 TIMES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967699 ↗

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.