MONOCRYL Y942GRecalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10705031218642), received between May 16, 2018 and Aug 14, 2024 — classified as 43 malfunctions.

The most frequently reported specific device problem is “Break” (29 reports).

2 other recalls cover devices cleared under the same FDA submission (K960653); 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT MASS REMOVAL PROCEDURE IN 2024 AND SUTURE WAS USED. DURING MASS REMOVAL, THE INCISION GOT INFECTED AND CAME APART. THE SUTURE WAS HANGING OUT, KNOTS WERE NOT INTACT AT SITE OF DEHISCENCE. SKIN WAS INFECTED, INFLAMED WITH DISCHARGE AT THIS LOCATION. THE SUTURE PULLED OUT OF THE TISSUE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Purulent Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 19981765 ↗
• MalfunctionMay 3, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ANIMAL SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. THE NEEDLES WERE FALLING OFF OF THE SUTURE MATERIAL. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19243288 ↗
• MalfunctionMay 3, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ANIMAL SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. THE NEEDLES WERE FALLING OFF OF THE SUTURE MATERIAL. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19243286 ↗
• MalfunctionFeb 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT BEFORE A PROCEDURE THE PRODUCT BROKE AND WAS UNABLE TO BE USED. THIS OCCURRED TWICE DURING THE SAME PROCEDURE WHERE THE NEEDLE FELL OFF. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711440 ↗
• MalfunctionFeb 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT BEFORE A PROCEDURE THE PRODUCT BROKE AND WAS UNABLE TO BE USED. THIS OCCURRED TWICE DURING THE SAME PROCEDURE WHERE THE NEEDLE FELL OFF. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711435 ↗
• MalfunctionAug 29, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CANINE SPAY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. WHILE ATTEMPTING TO TIE OFF, THE SUTURE WOULD SNAP AT THE KNOT. THEY LATER SWITCHED TO A DIFFERENT SUTURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646403 ↗
• MalfunctionAug 29, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CANINE SPAY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. WHILE ATTEMPTING TO TIE OFF, THE SUTURE WOULD SNAP AT THE KNOT. THEY LATER SWITCHED TO A DIFFERENT SUTURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646401 ↗
• MalfunctionAug 29, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CANINE SPAY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. WHILE ATTEMPTING TO TIE OFF, THE SUTURE WOULD SNAP AT THE KNOT. THEY LATER SWITCHED TO A DIFFERENT SUTURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646399 ↗
• MalfunctionAug 29, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CANINE SPAY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS DIFFICULT TO REMOVE FROM PACKAGE. AFTER 1ST PASS, IT BROKE FROM WHERE THE NEEDLE MEETS THE SUTURE. 2ND PACKAGE WAS OPENED, FINE TO REMOVE FROM PACKAGE, BUT SNAPPED UPON PLACEMENT OF 1ST KNOT. TRIED AGAIN WITH SAME SUTURE AND IT BROKE AGAIN. 3RD PACKAGE WAS OPENED AND AGAIN IT BROKE WHILE TRYING TO TIE OFF. AT THIS POINT, SHE HAD TO SWITCH TO ANOTHER SUTURE TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17645931 ↗
• MalfunctionAug 29, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CANINE SPAY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS DIFFICULT TO REMOVE FROM PACKAGE. AFTER 1ST PASS, IT BROKE FROM WHERE THE NEEDLE MEETS THE SUTURE. 2ND PACKAGE WAS OPENED, FINE TO REMOVE FROM PACKAGE, BUT SNAPPED UPON PLACEMENT OF 1ST KNOT. TRIED AGAIN WITH SAME SUTURE AND IT BROKE AGAIN. 3RD PACKAGE WAS OPENED AND AGAIN IT BROKE WHILE TRYING TO TIE OFF. AT THIS POINT, SHE HAD TO SWITCH TO ANOTHER SUTURE TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17645924 ↗
• MalfunctionAug 29, 2023Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CANINE SPAY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS DIFFICULT TO REMOVE FROM PACKAGE. AFTER 1ST PASS, IT BROKE FROM WHERE THE NEEDLE MEETS THE SUTURE. 2ND PACKAGE WAS OPENED, FINE TO REMOVE FROM PACKAGE, BUT SNAPPED UPON PLACEMENT OF 1ST KNOT. TRIED AGAIN WITH SAME SUTURE AND IT BROKE AGAIN. 3RD PACKAGE WAS OPENED AND AGAIN IT BROKE WHILE TRYING TO TIE OFF. AT THIS POINT, SHE HAD TO SWITCH TO ANOTHER SUTURE TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17645904 ↗
• MalfunctionAug 29, 2023Break; Difficult to Open or Remove Packaging Material; Break; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CANINE SPAY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS DIFFICULT TO REMOVE FROM PACKAGE. AFTER 1ST PASS, IT BROKE FROM WHERE THE NEEDLE MEETS THE SUTURE. 2ND PACKAGE WAS OPENED, FINE TO REMOVE FROM PACKAGE, BUT SNAPPED UPON PLACEMENT OF 1ST KNOT. TRIED AGAIN WITH SAME SUTURE AND IT BROKE AGAIN. 3RD PACKAGE WAS OPENED AND AGAIN IT BROKE WHILE TRYING TO TIE OFF. AT THIS POINT, SHE HAD TO SWITCH TO ANOTHER SUTURE TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17645896 ↗
• MalfunctionAug 17, 2023Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. BEFORE USE ON PATIENT, THE NEEDLE DETACHED FROM SUTURE UPON REMOVAL FROM PACKAGE. AFTER INVESTIGATION OF THE RETURNED SAMPLE, SHORT INSERTION WAS OBSERVED IN THE STRAND. THE VISUAL INSPECTION CONCLUDED THAT THE COMBINATION OF THE NEEDLE/SUTURE WAS DETACHED FROM THE NEEDLE SINCE THE INSERTION END OF THE SUTURE DID NOT MEET THE REQUIREMENT. BASED ON THE INFORMATION CURRENTLY AVAILABLE, SHORT INSERTION ISSUE WAS IDENTIFIED AS PULL OUT DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17564061 ↗
• MalfunctionDec 28, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CAT SPAY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. SIX PACKS WERE USED AND THREE OF THE SUTURES RELEASED. THERE WAS ONE CAT SPAY ON (B)(6) 2022 AND TWO ADDITIONAL ON (B)(6) 2022. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060239 ↗
• MalfunctionDec 28, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CAT SPAY PROCEDURE ON (B)(6)2022 AND SUTURE WAS USED. SIX PACKS WERE USED AND THREE OF THE SUTURES RELEASED. THERE WAS ONE CAT SPAY ON (B)(6) 2022 AND TWO ADDITIONAL ON (B)(6) 2022. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060234 ↗
• MalfunctionDec 28, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A CAT SPAY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. SIX PACKS WERE USED AND THREE OF THE SUTURES RELEASED. THERE WAS ONE CAT SPAY IN OCTOBER AND TWO ADDITIONAL ON (B)(6) 2022. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060218 ↗
• MalfunctionNov 11, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. POST-OP, IT WAS REPORTED THAT THE SUTURE COMING APART AFTER SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15781453 ↗
• MalfunctionNov 11, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. POST-OP, IT WAS REPORTED THAT THE SUTURE COMING APART AFTER SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15781439 ↗
• MalfunctionNov 11, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. POST-OP, IT WAS REPORTED THAT THE SUTURE COMING APART AFTER SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15781434 ↗
• MalfunctionOct 18, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE DOCTOR WAS TYING A MORRIS KNOT IN A PROCEDURE AND THE SUTURE BROKE. OPENED A DIFFERENT BOX WITH A DIFFERENT LOT NUMBER AND NO ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12652741 ↗
• MalfunctionOct 18, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE DOCTOR WAS TYING A MORRIS KNOT IN A PROCEDURE AND THE SUTURE BROKE. OPENED A DIFFERENT BOX WITH A DIFFERENT LOT NUMBER AND NO ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12652738 ↗
• MalfunctionOct 18, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE DOCTOR WAS TYING A MORRIS KNOT IN A PROCEDURE AND THE SUTURE BROKE. OPENED A DIFFERENT BOX WITH A DIFFERENT LOT NUMBER AND NO ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12652733 ↗
• MalfunctionOct 18, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. THE DOCTOR WAS TYING A MORRIS KNOT IN A PROCEDURE AND THE SUTURE BROKE. OPENED A DIFFERENT BOX WITH A DIFFERENT LOT NUMBER AND NO ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12652730 ↗
• MalfunctionJun 9, 2021Break; Break

  IT WAS REPORTED BY VET THAT A CAT UNDERWENT AN OVARIECTOMY/ANIMAL SURGERY ON (B)(6) 2021 AND THE SUTURE WAS USED. ADDITIONAL MIDLINE SIMPLE INTERRUPTED SUTURE WAS ALSO PERFORMED. ON (B)(6) 2021, A VET DESCRIBED THE LINEA SUTURE AS "RUPTURED" AND WAS NOT ABLE TO FIND THE FRAGMENT FROM THE SIMPLE INTERRUPTED SUTURE. IT APPEARED TO BE A SINGLE STRAND OF SUTURE MATERIAL, AND COULD NOT FIND THE CRANIAL ASPECT OF THE KNOT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971516 ↗
• MalfunctionJun 9, 2021Break; Break

  IT WAS REPORTED BY VET THAT A CAT UNDERWENT A OVARIECTOMY PROCEDURE ON (B)(6) 2021 AND THE SUTURE WAS USED. AFTER THE SURGERY, ON (B)(6) 2021, WITH THE OVERLYING SKIN CLOSURE APPEARING INTACT AND NORMAL, A SURGEON COULD NOT ABLE TO FIND THE FRAGMENT FROM THE SIMPLE INTERRUPTED SUTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971146 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K960653. 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
• Z-1311-2009 · Feb 2, 2009 · Terminated
  MONOCRYL (poliglecaprone 25 ) Suture, Ethicon Inc., A Johnson & Johnson Company, Somerville, NJ Sutures are intended for general soft tissue approximation and/or ligation.