MONOCRYL MCP493GRecalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10705031046566), received between Aug 27, 2018 and Sep 21, 2026 — classified as 2 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Break” (48 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Material Separation

  It was reported that a patient underwent an unknown procedure on (B)(6)2026 and suture was used. It was reported that the thread came off needle at the swage during suturing. New sutures were opened to complete procedure. No time delay was reported. Procedure was completed successfully. No fragments, X-rays, etc. No adverse events / consequences reported. No surgical delays reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842354 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NURSING FLOOR MANAGER CONTACTED ME TO LET ME KNOW THAT THEY HAD AN APPARENT BREAKAGE OF A NEEDLE ATTACHED TO A 5/0 MONOCRYL. THIS OCCURRED INTRAOPERATIVELY. IT WAS NOTICED THAT THE TIP OF THE NEEDLE WAS MISSING AS THE SUTURE WAS BEING HANDED OFF TO THE SCRUB NURSE. SHE COMMENTED THAT THIS HAD ALSO HAPPENED SOME MONTHS PRIOR, ALBEIT ON A 3/0 MONOCRYL. SHE INFORMED ME THAT THE NEEDLE TIP WAS NOT RECOVERED AND THAT THE PATIENT HAD BEEN SENT FOR A CT SCAN - WHICH SUGGESTED THAT THE NEEDLE TIP WAS IN-SITU. I ASKED HER TO RETAIN THE SUTURE AND NEEDLE - HOWEVER THESE HAD ALREADY BEEN DISPOSED. SHE DID TAKE PHOTOS OF THE DEVICE AND ITS PACKAGING WHICH SHE AGREED TO SHARE. I ASKED HER TO RETAIN THE PACKAGING AND QUARANTINE THE REMNANT OF THE SUTURE BOX FOR COLLECTION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24712695 ↗
• MalfunctionNov 14, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING SECOND TIME, NEEDLE AND SUTURE DETACH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555185 ↗
• MalfunctionOct 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CYST EXCISION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23203578 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY ON AN UNKNOWN DATE IN 2024 AND TOPICAL SKIN ADHESIVE WAS USED. 2 MONTHS PRIOR. AFTERWARDS, PATIENT PRESENTED WITH REDNESS AROUND THE INCISIONS. NOW, 2 MONTHS POD, PATIENT HAD REDNESS ACROSS THE ABDOMEN, NOT LIMITED TO AROUND THE LAP INCISION. SURGEON GAVE PATIENT STEROIDS. PATIENT FOLLOWED UP WITH A DERMATOLOGIST THAT CONCLUDED THAT IT WAS AN INFECTION. UNABLE TO TRACE LOT NUMBER OF ITEMS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 20902217 ↗
• MalfunctionMay 18, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SCRUB NURSE OPENED 1 PACKET AND REALIZED IT WAS A DOUBLE ARM INSTEAD OF A SINGLE NEEDLE. THE NEEDLE WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16954016 ↗
• MalfunctionSep 2, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WASN'T TIED. THE SUTURE WAS USED ON SKIN. THE SUTURE WAS INITIALLY PLACED INTERRUPTED. BREAKAGE OCCURRED DURING THE FIRST PASS THROUGH TISSUE. THE APPROXIMATE LOCATION OF SUTURE BREAKAGE WAS SIX INCHES IN RELATION TO NEEDLE. THE SUTURE DID BREAK IN TWO PIECES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15349633 ↗
• MalfunctionAug 31, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED ON PREAURICULAR SKIN. THE SUTURE BROKE IN TWO PIECES ON FIRST PASS THROUGH THE TISSUE. THE APPROXIMATE LOCATION OF SUTURE BREAKAGE WAS 16 CM IN RELATION TO NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15329069 ↗
• MalfunctionAug 31, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED ON PREAURICULAR SKIN. THE SUTURE WAS NOT TIED AND BROKE IN TWO PLACES ON FIRST PULL THROUGH THE SKIN. THE APPROXIMATE LOCATION OF SUTURE BREAKAGE WAS 9.7CM IN RELATION TO NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328889 ↗
• MalfunctionAug 30, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT DURING AN UNKNOWN PROCEDURE, THE SUTURE WAS TIED. THE SUTURE WAS USED ON SKIN. THE SUTURE INITIALLY WAS PLACED INTERRUPTED. BREAKAGE OCCURRED DURING THE SECOND PASS THROUGH TISSUE. THE APPROXIMATE LOCATION OF SUTURE BREAKAGE WAS SIX INCHES IN RELATION TO NEEDLE. THE SUTURE DID BREAK IN TWO PIECES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15323480 ↗
• MalfunctionAug 30, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT DURING AN UNKNOWN PROCEDURE, THE SUTURE WAS TIED. THE SUTURE WAS USED ON SKIN. THE SUTURE INITIALLY WAS PLACED INTERRUPTED. BREAKAGE OCCURRED DURING THE SECOND PASS THROUGH TISSUE. THE APPROXIMATE LOCATION OF SUTURE BREAKAGE WAS SIX INCHES IN RELATION TO NEEDLE. THE SUTURE DID BREAK IN TWO PIECES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15323466 ↗
• MalfunctionJul 25, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS NOT TIED. SUTURE WAS BEING USED ON SKIN AND BROKE IN TWO PIECES ON THE FIRST PASS AT SIX INCHES FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15100243 ↗
• MalfunctionJul 25, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS NOT TIED. SUTURE WAS BEING USED ON SKIN INITIALLY PLACED INTERRUPTED AND BROKE IN TWO PIECES ON THE FIRST PASS THROUGH TISSUE AT SIX INCHES FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15100239 ↗
• MalfunctionJul 25, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS NOT TIED. SUTURE WAS BEING USED ON SKIN, PREAURICULAR AND BROKE IN TWO PIECES ON THE FIRST PASS THROUGH TISSUE SUTURE BROKE BEFORE SUTURE COMPLETED AT 16CM FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15100238 ↗
• MalfunctionApr 12, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE WAS USED ON SKIN TISSUE AND WAS NOT TIED. THE SUTURE INITIALLY WAS PLACED INTERRUPTED. THE BREAKAGE OCCURRED DURING THE SECOND TISSUE PASS. IN RELATION TO THE NEEDLE THE BREAKAGE OCCURRED APPROXIMATELY SIX INCHES. THE SUTURE DID BREAK IN TWO PIECES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14089348 ↗
• MalfunctionApr 12, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE WAS USED ON FACE/RIGHT CHEEK TISSUE AND WAS NOT BEING TIED AT TIME OF BREAKAGE, WAS JUST BEING PULLED THRU TISSUE. THE SUTURE WAS INITIALLY PLACED INTERRUPTED. BREAKAGE OCCURRED DURING APPROXIMATELY EIGHT TISSUE PASSES BEFORE BREAKAGE. IN RELATION TO NEEDLE, THE APPROXIMATE LOCATION OF SUTURE BREAKAGE APPROXIMATELY TEN CENTIMETERS. THE SUTURE DID BREAK IN TWO PIECES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14089266 ↗
• MalfunctionMar 10, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN CLOSURE PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING THE SKIN THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13720826 ↗
• MalfunctionMar 10, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN CLOSURE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING THE SKIN THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13720816 ↗
• MalfunctionMar 10, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN CLOSURE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING THE SKIN THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13720805 ↗
• MalfunctionMar 10, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN CLOSURE PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING THE SKIN THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13720793 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT A HAND PROCEDURE IN (B)(6) 2020 AND SUTURE WAS USED FOR CLOSURE. SEVERAL WEEKS AFTER THE PROCEDURE, THE PATIENT STARTED BREAKING OUT AND HAS HAD FREQUENT DEGRANULATION'S "FLARE UPS" OF HER MAST CELL DISEASE SINCE THEN WHICH PUT HER INTO ANAPHYLACTIC SHOCK. WITH THE SUTURE, STARTED BREAKING OUT AROUND THE SITE WITH LOCALIZED MAST CELL REACTION AND PROBLEMS CASCADING FROM THAT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Anaphylactic Shock; Local Reaction

  MAUDE report 13636844 ↗
• MalfunctionJul 21, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202159 ↗
• MalfunctionJul 21, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202155 ↗
• MalfunctionJul 21, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202140 ↗
• MalfunctionJul 21, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 04/21/2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202128 ↗

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