MONOCRYL Y316HRecalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10705031058743), received between Jan 12, 2018 and Dec 3, 2025 — classified as 1 injury, 60 malfunctions.

The most frequently reported specific device problem is “Break” (43 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Material Separation; Material Separation

  IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT SUTURE DEGRADATION WAS OBSERVED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE ACCOUNT CONTACT THAT DURING AN UNKNOWN PROCEDURE THE NEEDLE POPPED OFF FROM THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705800 ↗
• MalfunctionMar 13, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE BROKE DOWN AND TWO WEEKS POST OP TO THE ORIGINAL PROCEDURE THEY PERFORMED A HERNIA REPAIR, THE BROKEN SUTURE WAS REMOVED. THE KNOTS WERE INTAKE. THE HERNIA WAS DISCOVERED ON (B)(6) 2025. THE PATIENT CAME BACK FOR THE SUTURE REMOVAL AND THE HERNIA WAS FOUND. THE HERNIA WAS PLUGGED UP BY ABDOMINAL FAT, THAT PLUGGED UP THE HOLE SO THE BLADDER DID NOT COME OUT. THAT WAS ADHERED TO THE LINEA. THE SUTURE WAS KEPT, ONE KNOT WAS RETAINED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia

  MAUDE report 21599053 ↗
• MalfunctionSep 30, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE CLINIC ORDERED Y316H BUT UPON OPENING THE PRODUCT PACKAGING, THE CLINIC FOUND INDIVIDUAL PACKETS OF Y30 TO BE CONTAINED WITHIN THE PACKAGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20339539 ↗
• MalfunctionFeb 27, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN UROLOGICAL SURGERY WITH DA VINCI ON AN UNKNOWN DATE AND A SUTURE WAS USED. DURING PROCEDURE, WHEN THE NEEDLE WAS PUT THROUGH THE TROCAR BEFORE HOLDING THE NEEDLE WITH A NEEDLE HOLDER, THE SUTURE WAS DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18793058 ↗
• MalfunctionJan 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE,THE SUTURE WAS EASILY BROKEN DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18486969 ↗
• MalfunctionJan 10, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE,THE SUTURE WAS EASILY BROKEN DURING USE.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18486963 ↗
• MalfunctionDec 26, 2023Material Separation; Material Separation

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE IS FALLING APART IN SURGEONS HAND. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18395261 ↗
• MalfunctionSep 19, 2023Break; Product Quality Problem; Defective Component; Break; Product Quality Problem; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON REPORTED THE MONOCRYL SUTURE THAT HE HAS BEEN USING FOR OVER A DECADE HAS CHANGED IN QUALITY THE LAST 6 MONTHS. THE SUTURE POOR HANDLING CHARACTERISTICS RESEMBLES A PROLENE. THE SUTURE HE IS USED TO HAS A STRETCHY LIKE FEEL, MINIMAL MEMORY AND TIES SECURELY. RECENTLY, THE MONOCRYL SUTURE IS UNRAVELING, AND KNOTS ARE NOT SECURELY TYING DOWN LOOSENING ONCE COMPLETE. HE IS HAVING TO THROW EXTRA KNOTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778132 ↗
• MalfunctionSep 19, 2023Break; Product Quality Problem; Defective Component; Break; Product Quality Problem; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON REPORTED THE MONOCRYL SUTURE THAT HE HAS BEEN USING FOR OVER A DECADE HAS CHANGED IN QUALITY THE LAST 6 MONTHS. THE SUTURE POOR HANDLING CHARACTERISTICS RESEMBLES A PROLENE. THE SUTURE HE IS USED TO HAS A STRETCHY LIKE FEEL, MINIMAL MEMORY AND TIES SECURELY. RECENTLY, THE MONOCRYL SUTURE IS UNRAVELING, AND KNOTS ARE NOT SECURELY TYING DOWN LOOSENING ONCE COMPLETE. HE IS HAVING TO THROW EXTRA KNOTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778130 ↗
• MalfunctionSep 19, 2023Break; Product Quality Problem; Defective Component; Break; Product Quality Problem; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON REPORTED THE MONOCRYL SUTURE THAT HE HAS BEEN USING FOR OVER A DECADE HAS CHANGED IN QUALITY THE LAST 6 MONTHS. THE SUTURE POOR HANDLING CHARACTERISTICS RESEMBLES A PROLENE. THE SUTURE HE IS USED TO HAS A STRETCHY LIKE FEEL, MINIMAL MEMORY AND TIES SECURELY. RECENTLY, THE MONOCRYL SUTURE IS UNRAVELING, AND KNOTS ARE NOT SECURELY TYING DOWN LOOSENING ONCE COMPLETE. HE IS HAVING TO THROW EXTRA KNOTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778129 ↗
• MalfunctionSep 19, 2023Break; Product Quality Problem; Defective Component; Break; Product Quality Problem; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON REPORTED THE MONOCRYL SUTURE THAT HE HAS BEEN USING FOR OVER A DECADE HAS CHANGED IN QUALITY THE LAST 6 MONTHS. THE SUTURE POOR HANDLING CHARACTERISTICS RESEMBLES A PROLENE. THE SUTURE HE IS USED TO HAS A STRETCHY LIKE FEEL, MINIMAL MEMORY AND TIES SECURELY. RECENTLY, THE MONOCRYL SUTURE IS UNRAVELING, AND KNOTS ARE NOT SECURELY TYING DOWN LOOSENING ONCE COMPLETE. HE IS HAVING TO THROW EXTRA KNOTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778104 ↗
• MalfunctionSep 19, 2023Break; Product Quality Problem; Defective Component; Break; Product Quality Problem; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON REPORTED THE MONOCRYL SUTURE THAT HE HAS BEEN USING FOR OVER A DECADE HAS CHANGED IN QUALITY THE LAST 6 MONTHS. THE SUTURE POOR HANDLING CHARACTERISTICS RESEMBLES A PROLENE. THE SUTURE HE IS USED TO HAS A STRETCHY LIKE FEEL, MINIMAL MEMORY AND TIES SECURELY. RECENTLY, THE MONOCRYL SUTURE IS UNRAVELING, AND KNOTS ARE NOT SECURELY TYING DOWN LOOSENING ONCE COMPLETE. HE IS HAVING TO THROW EXTRA KNOTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778098 ↗
• MalfunctionSep 19, 2023Break; Product Quality Problem; Defective Component; Break; Product Quality Problem; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON REPORTED THE MONOCRYL SUTURE THAT HE HAS BEEN USING FOR OVER A DECADE HAS CHANGED IN QUALITY THE LAST 6 MONTHS. THE SUTURE POOR HANDLING CHARACTERISTICS RESEMBLES A PROLENE. THE SUTURE HE IS USED TO HAS A STRETCHY LIKE FEEL, MINIMAL MEMORY AND TIES SECURELY. RECENTLY, THE MONOCRYL SUTURE IS UNRAVELING, AND KNOTS ARE NOT SECURELY TYING DOWN LOOSENING ONCE COMPLETE. HE IS HAVING TO THROW EXTRA KNOTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778097 ↗
• MalfunctionSep 19, 2023Break; Product Quality Problem; Defective Component; Break; Product Quality Problem; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON REPORTED THE MONOCRYL SUTURE THAT HE HAS BEEN USING FOR OVER A DECADE HAS CHANGED IN QUALITY THE LAST 6 MONTHS. THE SUTURE POOR HANDLING CHARACTERISTICS RESEMBLES A PROLENE. THE SUTURE HE IS USED TO HAS A STRETCHY LIKE FEEL, MINIMAL MEMORY AND TIES SECURELY. RECENTLY, THE MONOCRYL SUTURE IS UNRAVELING, AND KNOTS ARE NOT SECURELY TYING DOWN LOOSENING ONCE COMPLETE. HE IS HAVING TO THROW EXTRA KNOTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778095 ↗
• MalfunctionSep 19, 2023Break; Product Quality Problem; Defective Component; Break; Product Quality Problem; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON REPORTED THE MONOCRYL SUTURE THAT HE HAS BEEN USING FOR OVER A DECADE HAS CHANGED IN QUALITY THE LAST 6 MONTHS. THE SUTURE POOR HANDLING CHARACTERISTICS RESEMBLES A PROLENE. THE SUTURE HE IS USED TO HAS A STRETCHY LIKE FEEL, MINIMAL MEMORY AND TIES SECURELY. RECENTLY, THE MONOCRYL SUTURE IS UNRAVELING, AND KNOTS ARE NOT SECURELY TYING DOWN LOOSENING ONCE COMPLETE. HE IS HAVING TO THROW EXTRA KNOTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778048 ↗
• MalfunctionSep 19, 2023Break; Product Quality Problem; Defective Component; Break; Product Quality Problem; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON REPORTED THE MONOCRYL SUTURE THAT HE HAS BEEN USING FOR OVER A DECADE HAS CHANGED IN QUALITY THE LAST 6 MONTHS. THE SUTURE POOR HANDLING CHARACTERISTICS RESEMBLES A PROLENE. THE SUTURE HE IS USED TO HAS A STRETCHY LIKE FEEL, MINIMAL MEMORY AND TIES SECURELY. RECENTLY, THE MONOCRYL SUTURE IS UNRAVELING, AND KNOTS ARE NOT SECURELY TYING DOWN LOOSENING ONCE COMPLETE. HE IS HAVING TO THROW EXTRA KNOTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778047 ↗
• MalfunctionSep 6, 2023Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON REPORTED THE MONOCRYL SUTURE THAT HE HAS BEEN USING FOR OVER A DECADE HAS CHANGED IN QUALITY THE LAST 6 MONTHS. THE SUTURE POOR HANDLING CHARACTERISTICS RESEMBLES A PROLENE. THE SUTURE HE IS USED TO HAS A STRETCHY LIKE FEEL, MINIMAL MEMORY AND TIES SECURELY. RECENTLY, THE MONOCRYL SUTURE IS UNRAVELING, AND KNOTS ARE NOT SECURELY TYING DOWN LOOSENING ONCE COMPLETE. HE IS HAVING TO THROW EXTRA KNOTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17695736 ↗
• MalfunctionSep 5, 2023Break; Product Quality Problem; Defective Component; Break; Product Quality Problem; Defective Component

  IT WAS REPORTED A PATIENT UNDERWENT A ROBOTIC INGUINAL HERNIA PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE SUTURE IS UNRAVELING AND KNOTS ARE NOT SECURELY TYING DOWN LOOSENING ONCE COMPLETE. HE IS HAVING TO THROW MORE. NO REPORTED ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17685890 ↗
• MalfunctionSep 1, 2023Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. POST-OP, IT WAS REPORTED THAT THE CAT CAME BACK FROM SPAY SURGERIES WITH BROKEN INTERNAL SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17670655 ↗
• MalfunctionSep 1, 2023Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. POST-OP, IT WAS REPORTED THAT THE CAT CAME BACK FROM SPAY SURGERIES WITH BROKEN INTERNAL SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17670644 ↗
• MalfunctionSep 1, 2023Break; Break

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. POST-OP, IT WAS REPORTED THAT THE CAT CAME BACK FROM SPAY SURGERIES WITH BROKEN INTERNAL SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17670643 ↗
• MalfunctionJun 14, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS NOTED THAT THE PACKAGE HAD MICROSCOPIC HOLES IN THE PACKAGING. THERE WAS NO PATIENT CONSEQUENCES/USAGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131391 ↗
• MalfunctionJun 14, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS NOTED THAT THE PACKAGE HAD MICROSCOPIC HOLES IN THE PACKAGING. THERE WAS NO PATIENT CONSEQUENCES/USAGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131390 ↗
• MalfunctionJun 20, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPAYING & NEUTERING OF ANIMALS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. POST-OPERATIVELY, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 14749172 ↗
• MalfunctionJun 20, 2022Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SPAYING & NEUTERING OF ANIMALS PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. POST-OPERATIVELY, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 14749171 ↗

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.