MONOCRYL MCP304HRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031046344), received between Jun 26, 2019 and Jun 23, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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.

• MalfunctionJun 23, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE, A SUTURE UNRAVELED AFTER SUTURING AND UPON INITIATING THE INITIAL KNOTS. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25599425 ↗
• MalfunctionApr 8, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. BEFORE OPENING THE PACKAGE, IT WAS FOUND THAT THE PACKAGE WAS INCOMPLETE AND THERE WAS A CONCERN ABOUT CONTAMINATION. THERE WERE NO DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818752 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CERVICAL LYMPH NODE DISSECTION SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. AT 14:30, THE PATIENT WAS DIAGNOSED WITH LYMPH NODE ENLARGEMENT AND UNDERWENT SURGERY. DURING THE SURGERY, WHEN THE SUTURE WAS USED, IT BROKE WHEN IT WAS GENTLY PULLED, CAUSING THE SURGERY TO BE INTERRUPTED. THE SUTURE WAS REPLACED AND THE SURGERY CONTINUED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851601 ↗
• MalfunctionDec 4, 2025Failure to Degrade; Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL SUBTOTAL THYROIDECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AT 9:00 AM AFTER DISCOVERING A PROTRUSION IN THE NECK FOR OVER A MONTH. ON THE SECOND DAY AFTER ADMISSION, SURGERY WAS PERFORMED, AND THE DOCTOR USED SUTURE TO SUTURE THE PATIENT'S SURGICAL INCISION. AFTER MORE THAN 3 MONTHS OF POSTOPERATIVE FOLLOW-UP, THE PATIENT WAS FOUND TO HAVE OBVIOUS NODULES AND ELEVATIONS AT THE SITE OF SUTURE AND KNOTTING OF THE SURGICAL INCISION. NO ADVERSE REACTIONS SUCH AS REDNESS, SWELLING, SUBCUTANEOUS PUS ACCUMULATION, ETC. WERE OBSERVED, BUT IT AFFECTED THE APPEARANCE OF THE PATIENT'S NECK. CURRENTLY, OBSERVATION IS CONTINUING AND NO FURTHER TREATMENT HAS BEEN CARRIED OUT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Local Reaction; Pocket Erosion

  MAUDE report 23714864 ↗
• MalfunctionApr 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE BREAKS HALFWAY THROUGH USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21864219 ↗
• MalfunctionJul 22, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN ANIMAL SURGERY ON (B)(6) 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS TAKEN OUT OF THE BOX AND FOUND TO BE INCORRECT. THE CORRECT PRODUCT WAS SUPPOSED TO BE A DIFFERENT PRODUCT, AND THE BOX DID HAVE PROPER PACKAGING. THE SUTURE IN THE BOX WAS NOT CORRECT. THE PROCEDURE WAS COMPLETED WITH NO HARM. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15084953 ↗
• MalfunctionAug 23, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME LOOSE FROM THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12356689 ↗
• MalfunctionMar 12, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2021 AND SUTURE WAS USED. DURING THE SURGERY WHEN OPENING THE PACKAGE, IT WAS NOTED THAT THE PACKAGING CONTAINED BLACK SUTURE INSTEAD OF VIOLET. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11475598 ↗
• MalfunctionMar 12, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6)2021 AND SUTURE WAS USED. DURING THE SURGERY WHEN OPENING THE PACKAGE, IT WAS NOTED THAT THE PACKAGING CONTAINED BLACK SUTURE INSTEAD OF VIOLET. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11475595 ↗
• MalfunctionJan 15, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM A NEEDLE WHEN IT WAS OPENED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT NEEDLE WAS BROKEN IN THE SWAGE AREA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9590717 ↗
• MalfunctionJun 26, 2019Material Separation; Material Separation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8735630 ↗