MONOCRYL MCP943GRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705031218604), received between Mar 8, 2021 and Jun 16, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE ETHICON SUTURE KEEPS BREAKING UP IN THE MIDDLE OF THE PROCEDURE AT MID TIE. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. CUSTOMER IS ASKING FOR A REPLACEMENT OF THE 2 BOXES. THE DEVICE WAS RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25524478 ↗
• MalfunctionJun 16, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE ETHICON SUTURE KEEPS BREAKING UP IN THE MIDDLE OF THE PROCEDURE AT MID TIE. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. CUSTOMER IS ASKING FOR A REPLACEMENT OF THE 2 BOXES. THE DEVICE WAS RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25524474 ↗
• MalfunctionJun 16, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT DURING AN UNKNOWN PROCEDURE, THE NEEDLES KEPT BREAKING WHILE TRYING TO STITCH A PATIENT. NO ADDITIONAL INFORMATION PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25523002 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT DEVELOPED A RESISTANT BACTERIA INFECTION ON THE TOP SKIN LAYER. THE BOX WAS THROWN AWAY SO NO PRODUCT, BATCH OR SERIAL NUMBER IS AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 24987699 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT AN ANIMAL UNDERWENT A TPLO (TIBIAL PLATEAU LEVELING OSTEOTOMY) PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE INTRADERMAL SUTURE BROKE IN 10 TO 14 DAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24290492 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT AN ANIMAL UNDERWENT A TPLO (TIBIAL PLATEAU LEVELING OSTEOTOMY) PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE INTRADERMAL SUTURE BROKE IN 10 TO 14 DAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24290489 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT AN ANIMAL UNDERWENT A TPLO (TIBIAL PLATEAU LEVELING OSTEOTOMY) PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE INTRADERMAL SUTURE BROKE IN 10 TO 14 DAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24290488 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT AN ANIMAL UNDERWENT A TPLO (TIBIAL PLATEAU LEVELING OSTEOTOMY) PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE INTRADERMAL SUTURE BROKE IN 10 TO 14 DAYS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24290483 ↗
• MalfunctionJun 10, 2025Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT THE SUTURE FALLING APART IN SURGERY, WHEN HOLDING TO TIE OFF, IT BREAKS RIGHT WHERE THE FORCEPS ARE HOLDING ONTO IT "FEELS LIKE DRIED OUT SUTURE". 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 22179358 ↗
• MalfunctionMay 1, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A VETERINARY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THERE WAS AN ISSUE WITH THE SUTURE PULLING OUT OF THE RACETRACK AND BREAKING. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19221499 ↗
• MalfunctionSep 12, 2023Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE PRACTICE MANAGER FOR (B)(6) HOSPITAL THAT THEY ONLY UTILIZE ETHICON SUTURE WITHIN OUR PRACTICE, AND RECENTLY WE HAD A BOX OF SUTURE THAT WAS BELOW EXPECTATION. MY DOCTOR HAD REPEATED ISSUES WITH EVERY PACK HE OPENED OUT OF THIS BOX- THE TENSILE STRENGTH AND THE MEMORY JUST WASN¿T WHAT WE HAVE COME TO EXPECT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17733839 ↗
• MalfunctionSep 12, 2023Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE PRACTICE MANAGER FOR COUNTRYSIDE VETERINARY HOSPITAL THAT THEY ONLY UTILIZE ETHICON SUTURE WITHIN OUR PRACTICE, AND RECENTLY WE HAD A BOX OF SUTURE THAT WAS BELOW EXPECTATION. MY DOCTOR HAD REPEATED ISSUES WITH EVERY PACK HE OPENED OUT OF THIS BOX- THE TENSILE STRENGTH AND THE MEMORY JUST WASN¿T WHAT WE HAVE COME TO EXPECT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17733838 ↗
• MalfunctionSep 12, 2023Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE PRACTICE MANAGER FOR COUNTRYSIDE VETERINARY HOSPITAL THAT THEY ONLY UTILIZE ETHICON SUTURE WITHIN OUR PRACTICE, AND RECENTLY WE HAD A BOX OF SUTURE THAT WAS BELOW EXPECTATION. MY DOCTOR HAD REPEATED ISSUES WITH EVERY PACK HE OPENED OUT OF THIS BOX- THE TENSILE STRENGTH AND THE MEMORY JUST WASN¿T WHAT WE HAVE COME TO EXPECT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17733837 ↗
• MalfunctionApr 27, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CASTRATION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. ON (B)(6) 2023, IT WAS NOTED THAT THE SUTURE CAME UNDONE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 16826159 ↗
• MalfunctionDec 30, 2022Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN EXPLORATORY PROCEDURE AFTER SWALLOWING A GOLF BALL ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. OPENED A NEW BOX OF 2/0 SUTURE AND IT SEEMED TO BREAK A LOT EASIER. NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16077650 ↗
• MalfunctionDec 30, 2022Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN EXPLORATORY PROCEDURE AFTER SWALLOWING A GOLF BALL ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. OPENED A NEW BOX OF 2/0 SUTURE AND IT SEEMED TO BREAK A LOT EASIER. NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16077648 ↗
• MalfunctionMar 8, 2021Break; Break

  IT WAS REPORTED THAT A DOG UNDERWENT A SPAY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN SECURING KNOTS WHEN TYING OFF BOTH UTERINE PEDICLES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11441113 ↗

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