MONOCRYL MCP922HRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705031046726), received between Apr 16, 2019 and May 11, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K050845, K201996); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT N ANIMAL UNDERWENT A MASS REMOVAL PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT DURING MASS REMOVAL PROCEDURE SUTURE BROKEN IN MID SURGERY. PROCEDURE WAS DELAYED BY 10 MINUTES. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142669 ↗
• MalfunctionJun 18, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN ANIMAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE INTERRUPTED SUTURES HAD 80% OF THESE SUTURES FRAYED AND NO LONGER INTACT OR HOLDING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22287420 ↗
• MalfunctionAug 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLE BROKE OFF OF THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986359 ↗
• MalfunctionAug 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. THE NEEDLE BROKE OFF OF THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986295 ↗
• MalfunctionJun 21, 2021Material 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 NEEDLE PULLED OFF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12031690 ↗
• MalfunctionJun 21, 2021Material 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 NEEDLE PULLED OFF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12031689 ↗
• MalfunctionApr 18, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY A VETERINARIAN THAT AN ANIMAL UNDERWENT A MASS REMOVAL (ON TONGUE) PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. IMMEDIATELY, UPON RECOVERY, THE PATIENT EXPERIENCED EXCESSIVE BLEEDING. THE PATIENT HAD TO BE RE-ANESTHETIZED. ALL THE SUTURES WERE MISSING. REPLACED WITH DIFFERENT SUTURE.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 8528691 ↗
• MalfunctionApr 18, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY A VETERINARIAN THAT AN ANIMAL UNDERWENT A DENTAL EXTRACTION PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. POST OPERATIVELY, WHILE THE PATIENT WAS STILL IN THE HOSPITAL BUT RECOVERED, THE PATIENT EXPERIENCED BLEEDING FROM THE MOUTH. THE SUTURE HAD COME UNDONE AND WAS NOT PRESENT. THE PATIENT WAS TREATED WITH PRESSURE AND SILVER NITRATE TO CONTROL BLEEDING.

  Patient problems: No Code Available

  MAUDE report 8528449 ↗
• MalfunctionApr 17, 2019Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY A VETERINARIAN THAT AN ANIMAL UNDERWENT A DENTAL EXTRACTION PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE HAS POSSIBLY NOT HELD BECAUSE OF THE KNOTS COMING UNDONE. IT WAS REPORTED THAT SEVERAL DAYS POST OP ON (B)(6) 2019 , THE ANIMAL EXPERIENCED DEHISCENCE AND BLEEDING FROM THE MOUTH. THE SUTURES WERE INFECTED AND SOME WERE MISSING. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND HEALED BY SECONDARY INTENTION. POST-OP DIRECTIONS WERE FOLLOWED.

  Patient problems: No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 8525613 ↗
• MalfunctionApr 16, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A DENTAL EXTRACTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE KNOT WAS UNTIED OR THE ANIMAL EXPERIENCED A DEHISCENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 8518851 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050845, K201996. One submission often covers many models, so check the product and lot details in each record.

• Z-2149-2024 · May 10, 2024 · Open, Classified
  MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CO
• Z-1312-2009 · Feb 2, 2009 · Terminated
  MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture; Ethicon, Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and/o