MONOCRYL Y266HRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10705031058637), received between Mar 5, 2018 and Apr 10, 2026 — classified as 7 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Break” (23 reports).

2 other recalls cover devices cleared under the same FDA submission (K964072); 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Break; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT SUTURE IS NOT 19MM THAT WAS WITHIN THE PACKAGING. POSSIBLE MANUFACTURER ISSUE WHERE THE OUTSIDE PACKAGING SAYS ONE (MM) SIZE WHILE INSIDE THE PRODUCT IS DIFFERENT (MM). IN ADDITION, BREAKING IS COMMON AND THE SUTURE IS NOT STAYING WITHIN. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844933 ↗
• MalfunctionApr 10, 2026Break; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT SUTURE IS NOT 19MM THAT WAS WITHIN THE PACKAGING. POSSIBLE MANUFACTURER ISSUE WHERE THE OUTSIDE PACKAGING SAYS ONE (MM) SIZE WHILE INSIDE THE PRODUCT IS DIFFERENT (MM). IN ADDITION, BREAKING IS COMMON AND THE SUTURE IS NOT STAYING WITHIN. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844811 ↗
• MalfunctionMar 16, 2026Break; Material Separation; Device Markings/Labelling Problem

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT SUTURE IS NOT 19MM THAT WAS WITHIN THE PACKAGING. POSSIBLE MANUFACTURER ISSUE WHERE THE OUTSIDE PACKAGING SAYS ONE (MM) SIZE WHILE INSIDE THE PRODUCT IS DIFFERENT (MM). IN ADDITION, BREAKING IS COMMON AND THE SUTURE IS NOT STAYING WITHIN. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24606885 ↗
• MalfunctionMar 16, 2026Break; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT SUTURE IS NOT 19MM THAT WAS WITHIN THE PACKAGING. POSSIBLE MANUFACTURER ISSUE WHERE THE OUTSIDE PACKAGING SAYS ONE (MM) SIZE WHILE INSIDE THE PRODUCT IS DIFFERENT (MM). IN ADDITION, BREAKING IS COMMON AND THE SUTURE IS NOT STAYING WITHIN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604153 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE OR HIP SURGERY ON AN UNKNOWN DATE AND SUTURE WITH A PS1 OR CT1 NEEDLE WAS USED. THE PATIENT PRESENTED WITH SUTURE SPITTING BETWEEN WEEK 4 AND 8. THE PATIENT WAS GIVEN ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 22610793 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE OR HIP SURGERY ON AN UNKNOWN DATE AND SUTURE WITH A PS1 OR CT1 NEEDLE WAS USED. THE PATIENT PRESENTED WITH SUTURE SPITTING BETWEEN WEEK 4 AND 8. THE PATIENT WAS GIVEN ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 22610792 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE OR HIP SURGERY ON AN UNKNOWN DATE AND SUTURE WITH A PS1 OR CT1 NEEDLE WAS USED. THE PATIENT PRESENTED WITH SUTURE SPITTING BETWEEN WEEK 4 AND 8. THE PATIENT WAS GIVEN ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 22610790 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE OR HIP SURGERY ON AN UNKNOWN DATE AND SUTURE WITH A PS1 OR CT1 NEEDLE WAS USED. THE PATIENT PRESENTED WITH SUTURE SPITTING BETWEEN WEEK 4 AND 8. THE PATIENT WAS BROUGHT BACK TO OR TO REMOVE AND GIVEN ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 22610789 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE OR HIP SURGERY ON AN UNKNOWN DATE AND SUTURE WITH A PS1 OR CT1 NEEDLE WAS USED. THE PATIENT PRESENTED WITH SUTURE SPITTING BETWEEN WEEK 4 AND 8. THE PATIENT WAS GIVEN ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 22610788 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE OR HIP SURGERY ON AN UNKNOWN DATE AND SUTURE WITH A PS1 OR CT1 NEEDLE WAS USED. THE PATIENT PRESENTED WITH SUTURE SPITTING BETWEEN WEEK 4 AND 8. THE PATIENT WAS BROUGHT BACK TO OR TO REMOVE AND GIVEN ANTIBIOTICS ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 22610783 ↗
• MalfunctionJun 2, 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 DOCTOR COMPLAINED ABOUT THE QUALITY OF THE SUTURE. IT BREAKS EASILY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127863 ↗
• MalfunctionJun 2, 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 DOCTOR COMPLAINED ABOUT THE QUALITY OF THE SUTURE. IT BREAKS EASILY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127843 ↗
• MalfunctionJun 2, 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 DOCTOR COMPLAINED ABOUT THE QUALITY OF THE SUTURE. IT BREAKS EASILY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127833 ↗
• MalfunctionJun 2, 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 DOCTOR COMPLAINED ABOUT THE QUALITY OF THE SUTURE. IT BREAKS EASILY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127825 ↗
• MalfunctionJun 2, 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 DOCTOR COMPLAINED ABOUT THE QUALITY OF THE SUTURE. IT BREAKS EASILY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127821 ↗
• MalfunctionJun 2, 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 DOCTOR COMPLAINED ABOUT THE QUALITY OF THE SUTURE. IT BREAKS EASILY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127805 ↗
• MalfunctionJun 2, 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 DOCTOR COMPLAINED ABOUT THE QUALITY OF THE SUTURE. IT BREAKS EASILY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127778 ↗
• MalfunctionJun 2, 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 DOCTOR COMPLAINED ABOUT THE QUALITY OF THE SUTURE. IT BREAKS EASILY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127750 ↗
• MalfunctionJun 2, 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 DOCTOR COMPLAINED ABOUT THE QUALITY OF THE SUTURE. IT BREAKS EASILY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127745 ↗
• MalfunctionJun 2, 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 DOCTOR COMPLAINED ABOUT THE QUALITY OF THE SUTURE. IT BREAKS EASILY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127733 ↗
• MalfunctionJun 2, 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 DOCTOR COMPLAINED ABOUT THE QUALITY OF THE SUTURE. IT BREAKS EASILY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127713 ↗
• MalfunctionJun 2, 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 DOCTOR COMPLAINED ABOUT THE QUALITY OF THE SUTURE. IT BREAKS EASILY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127677 ↗
• MalfunctionJun 6, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE REVERSE CUTTING NEEDLE WAS DIFFERENT THAN IT USED TO BE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17071242 ↗
• MalfunctionJun 6, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE REVERSE CUTTING NEEDLE WAS DIFFERENT THAN IT USED TO BE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17071233 ↗
• MalfunctionJun 6, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE REVERSE CUTTING NEEDLE WAS DIFFERENT THAN IT USED TO BE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17071229 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964072. One submission often covers many models, so check the product and lot details in each record.

• Z-0487-2025 · Oct 8, 2024 · Open, Classified
  MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and
• 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