MONOCRYL Y416HRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705031059122), received between Jun 27, 2018 and Mar 19, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 10, 2024Class IIOpen, Classified

   Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

   Z-2148-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Device Markings/Labelling Problem; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE ACCOUNT CONTACT THAT THEY PURCHASED A BOX FROM A DISTRIBUTOR OF THIS DEVICE HOWEVER THAT BOX HAS SPANISH LANGUAGE ON IT, THEREFORE IT IS DIFFICULT TO UNDERSTAND WHAT ARE THE DETAILS OF THE PRODUCT ON IT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638715 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY UNDERWENT A PLASTIC SURGERY ON THE ANKLE AREA TO REMOVE A GROWTH ON (B)(6) 2025 AND SUTURE WAS USED THE INNER STITCHES. POST-OP, THE PATIENT DEVELOPED YELLOW OOZING AROUND STITCHED AREA, REDNESS AROUND THE STITCHED AREA AND THE APPEARANCE OF SOME RED BLISTERS NEAR THE SUTURED AREA. THIS WAS COINCIDENT WITH THE STITCHES DISSOLVING. THE PATIENT CONTACTED THE SURGEON ON (B)(6) 2025 WHO PRESCRIBED AN ANTIBIOTIC. THE PATIENT WAS ALSO TREATED WITH TOPICAL NEOSPORIN. TWO WEEKS LATER, THE PATIENT DEVELOPED A RED ITCHY RASH FROM THE NECK TO THE UPPER LEGS. THE PATIENT WAS TREATED WITH BENADRYL. IN A POST OP MEETING WITH THE SURGEON ON (B)(6) 2025, THE DOCTOR CONFIRMED THE SYMPTOMS WERE INDICATIVE OF POTENTIAL ALLERGIC REACTION TO DISSOLVABLE STITCHES. THE PATIENT DID NOT REQUIRE A REVISION SURGERY. THE PATIENT WAS PRESCRIBED ANTIBIOTIC, TOPICAL TREATMENT AND ANTIHISTAMINE AFTER DEVELOPING AN INFECTION, INFLAMMATION INCLUDING BLISTERING AROUND THE SUTURE AREA AND A BODY RASH. THE PATIENT EXPERIENCED A DELAY IN HEALING AND HAS ADDITIONAL FOLLOW UP WITH THE SURGEON TO PROVIDE CARE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blister; Erythema; Fluid Discharge; Hypersensitivity/Allergic reaction; Impaired Healing; Inflammation; Itching Sensation; Rash; Unspecified Infection

  MAUDE report 23479641 ↗
• MalfunctionMar 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SEVERAL SUTURES HAVE BEEN DAMAGED DURING SURGERY. ALL OF THEM WITH THE SAME REFERENCE AND SAME LOT. THE NEEDLE WAS SEPARATED FROM THE THREAD IN THE PATIENT'S ABDOMEN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21541010 ↗
• MalfunctionMar 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SEVERAL SUTURES HAVE BEEN DAMAGED DURING SURGERY. ALL OF THEM WITH THE SAME REFERENCE AND SAME LOT. THE NEEDLE WAS SEPARATED FROM THE THREAD IN THE PATIENT'S ABDOMEN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21541009 ↗
• MalfunctionMar 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SEVERAL SUTURES HAVE BEEN DAMAGED DURING SURGERY. ALL OF THEM WITH THE SAME REFERENCE AND SAME LOT. THE NEEDLE WAS SEPARATED FROM THE THREAD IN THE PATIENT'S ABDOMEN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21540828 ↗
• MalfunctionMar 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SEVERAL SUTURES HAVE BEEN DAMAGED DURING SURGERY. ALL OF THEM WITH THE SAME REFERENCE AND SAME LOT. THE NEEDLE WAS SEPARATED FROM THE THREAD IN THE PATIENT'S ABDOMEN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21540826 ↗
• MalfunctionFeb 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE SUTURE WAS CHECKED OUTSIDE THE PATIENT, IT WAS USED IN THE PATIENT AND THE NEEDLE WAS SEPARATED FROM THE THREAD IN THE ABDOMEN. THIS OCCURRED WITH TWO SUTURES FROM THE SAME BATCH. THE REFERENCE WAS: (B)(4). THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21450627 ↗
• MalfunctionFeb 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE SUTURE WAS CHECKED OUTSIDE THE PATIENT, IT WAS USED IN THE PATIENT AND THE NEEDLE WAS SEPARATED FROM THE THREAD IN THE ABDOMEN. THIS OCCURRED WITH TWO SUTURES FROM THE SAME BATCH. THE REFERENCE WAS: Y416H. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21450619 ↗
• InjurySep 8, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON AN UNKNOWN DATE AND SUTURE WAS USED. EIGHT WEEKS POST OP, THE WOUND DEHISCED. IT WAS INFECTED AND NO SUTURES WERE PRESENT. IT WAS WASHED AND RE-SUTURED. THE PATIENT WAS PLACED ON ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 15380722 ↗
• MalfunctionJan 29, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE TIP BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9642217 ↗
• MalfunctionFeb 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND A SUTURE WAS USED. DURING SURGERY IT BROKE OFF THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8300982 ↗
• MalfunctionOct 30, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. DURING SURGERY, THE NEEDLE BROKE IN THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8019994 ↗
• MalfunctionJun 27, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY VET THAT THE ANIMAL UNDERWENT AN ANIMAL PROCEDURE IN 2018 AND THE SUTURE WAS USED. AFTER THE PROCEDURE, THE INTERNAL SUTURES DISSOLVED WITHIN A FEW DAYS OF THE PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7643232 ↗

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