MONOCRYL Y936HRecalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 10705031059917), received between Feb 12, 2018 and Sep 24, 2026 — classified as 4 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Break” (33 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 8, 2024Open, Classified

   Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.

   Z-0487-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Break

  It was reported a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. Brittle hair strands, breaking during use. Additional information has been requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888515 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN COLON RESECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP THAT DURING A COLON RESECTION, WHILE SUTURING THE TIP OF THE NEEDLE SNAPPED OFF. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291658 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN COLON RESECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP THAT DURING A COLON RESECTION, WHILE SUTURING THE TIP OF THE NEEDLE SNAPPED OFF. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291655 ↗
• MalfunctionSep 11, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE BROKE WHEN SEWING IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THE LOT IS UNAVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026769 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN TOTAL KNEE PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A DEHISCENCE. NO PATIENT INFECTION WAS NOTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Wound Dehiscence

  MAUDE report 22311112 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN TOTAL HIP PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A DEHISCENCE. NO PATIENT INFECTION WAS NOTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22310885 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN TOTAL KNEE PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A DEHISCENCE. NO PATIENT INFECTION WAS NOTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Wound Dehiscence

  MAUDE report 22310743 ↗
• MalfunctionJun 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST MAMMOPLASTY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE TIP OF THE NEEDLE IS BROKEN DURING MAMMOPLASTY SURGERY WITH IMPLANT. FRAGMENTS GENERATED BUT REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW SUTURE WITHOUT DELAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204227 ↗
• MalfunctionMar 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. SUTURE SNAPPED IN THE MIDDLE OF THE SUTURE DURING SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676757 ↗
• MalfunctionFeb 25, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21462033 ↗
• MalfunctionFeb 25, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21461845 ↗
• MalfunctionFeb 24, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THREAD BREAKS IN THE FIRST PASSAGE OF SUTURE. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21453824 ↗
• MalfunctionJan 17, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN LAP HYSTERECTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE TIP OF THE NEEDLE BROKEN DURING PORT CLOSURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179162 ↗
• MalfunctionNov 26, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLEEVE GASTRECTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, MONOFILAMENT SUTURE SPLIT INTO FEW STRANDS. SURGEON MENTION THAT THE SUTURE WAS STRETCHED AND ELONGATED AT THE END OF THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20778845 ↗
• MalfunctionNov 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SLEEVE GASTRECTOMY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SURGEON NOTICED THE TIP OF THE NEEDLE WAS BROKEN DURING THE SUTURING OF THE LAST TROCAR PORT (3RD TROCAR PORT). PARTS OF THE SUBCUTANEOUS FAT WERE REMOVED TO ENSURE THERE IS NO NEEDLE RESIDUALS REMAINED IN PATIENT BODY. X-RAY SCANNING WAS DONE AT THE WARD AS WELL AND RESULTS SHOWED NO FOREIGN BODY IS LEFT INSIDE THE PATIENT BODY. REMARK: THERE WERE A TOTAL OF THREE PORT HOLES ON THE PATIENT BODY AND ALL HOLES WERE SUTURED USING THE SAME SUTURE. THE NEEDLE WAS WORKING FINE WHEN SUTURING THE FIRST TWO TROCAR PORTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20774485 ↗
• MalfunctionNov 1, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY THE DISTRIBUTOR PER CUSTOMER THAT THE BOX OF 3/0 SUTURE HAD 4/0 SUTURE BOATS IN IT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20592186 ↗
• MalfunctionOct 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, DETACHMENT OF THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20473347 ↗
• MalfunctionAug 28, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE CUSTOMER RECEIVED A PACK OF SUTURE THAT HAD THE WRONG NEEDLE TYPE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20085796 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE THREADS ARE FRAGILE WHEN HANDLED, BREAKING DURING USE, BOTH USED IN THE SAME SURGERY. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20024844 ↗
• MalfunctionAug 15, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. WHEN THEY OPENED THE PACKAGE, THE WRONG NEEDLE WAS ON THE SUTURE. THE ACCOUNT ALLEGES THE PACKAGES WERE CORRECT BUT THE NEEDLE ATTACHED TO THE SUTURE WAS WRONG. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19997526 ↗
• MalfunctionAug 6, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE CUSTOMER RECEIVED A PACK OF SUTURE THAT HAD THE WRONG NEEDLE TYPE. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917825 ↗
• MalfunctionMay 2, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. THE BOX WAS CORRECT BUT THE NEEDLE INSIDE WAS NOT. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19234304 ↗
• MalfunctionApr 9, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, QUITE A FEW SUTURES WERE OPENED BEFORE NOTICING A PACKAGING DEFECT. THE REPRESENTATIVE HAD ORDERED 3-0 PS-1. THE BOX AND SUTURE PACKAGE WERE LABELED CORRECTLY, BUT THE SUTURES WERE ALL COMING OUT A P-3 SIZE. TWO BOXES WERE AFFECTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19074184 ↗
• MalfunctionApr 9, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, QUITE A FEW SUTURES WERE OPENED BEFORE NOTICING A PACKAGING DEFECT. THE REPRESENTATIVE HAD ORDERED 3-0 PS-1. THE BOX AND SUTURE PACKAGE WERE LABELED CORRECTLY, BUT THE SUTURES WERE ALL COMING OUT A P-3 SIZE. TWO BOXES WERE AFFECTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19074183 ↗
• MalfunctionMar 8, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. SUTURE MATERIAL DETACHED FROM NEEDLE DURING SUTURING NO ADVERSE PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866294 ↗

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-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