Coated VICRYL J442HRecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10705031039933), received between Apr 25, 2019 and Oct 10, 2025 — classified as 1 injury, 38 malfunctions.

The most frequently reported specific device problem is “Break” (24 reports).

3 other recalls cover devices cleared under the same FDA submission (K022269); 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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, SURGEON WAS ATTEMPTING TO RELOAD NEEDLE AFTER THROWING A STITCH WITH NEEDLE DRIVER WHEN THE TIP OF NEEDLE BROKE OFF. SURGEON WAS 100% CERTAIN NEEDLE REMNANT WAS NOT IN THE PATIENT. THE NEEDLE TIP WAS NOT RECOVERED. SURGEON OFFERED X-RAY BY STAFF IN ATTEMPT TO LOCATE BUT DECLINED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23268159 ↗
• MalfunctionJul 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE AND NEEDLE ARE DISCONNECTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22513181 ↗
• MalfunctionSep 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. ANOTHER LIKE DEVICE WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20299782 ↗
• MalfunctionSep 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. ANOTHER LIKE DEVICE WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20299780 ↗
• MalfunctionSep 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. ANOTHER LIKE DEVICE WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20299778 ↗
• MalfunctionSep 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. ANOTHER LIKE DEVICE WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20299777 ↗
• MalfunctionSep 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. ANOTHER LIKE DEVICE WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20299774 ↗
• MalfunctionJul 10, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024, AND SUTURE WAS USED. THEY RECEIVED A BOX OF SUTURE THAT WAS PACKED IN THE BOX LABELED FOR A DIFFERENT PRODUCT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19710893 ↗
• MalfunctionJun 24, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLE CAME OFF THE SUTURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19593243 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT PLASTIC SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, NINETEEN OUT OF THIRTY-SIX SUTURES BROKE AT THE NEEDLE CONNECTION; NEEDLE AND SUTURE SIMPLY SEPARATED, NO FRAGMENTS WERE GENERATED. THE SURGEON TRIED MORE SUTURES FROM SAME BOX THEN EVENTUALLY OPENED A NEW BOX, THE REMAINING SEVENTEEN WERE NOT USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139623 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT PLASTIC SURGERY ON APRIL 14, 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, NINETEEN OUT OF THIRTY-SIX SUTURES BROKE AT THE NEEDLE CONNECTION; NEEDLE AND SUTURE SIMPLY SEPARATED, NO FRAGMENTS WERE GENERATED. THE SURGEON TRIED MORE SUTURES FROM SAME BOX THEN EVENTUALLY OPENED A NEW BOX, THE REMAINING SEVENTEEN WERE NOT USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139622 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT PLASTIC SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, NINETEEN OUT OF THIRTY-SIX SUTURES BROKE AT THE NEEDLE CONNECTION; NEEDLE AND SUTURE SIMPLY SEPARATED, NO FRAGMENTS WERE GENERATED. THE SURGEON TRIED MORE SUTURES FROM SAME BOX THEN EVENTUALLY OPENED A NEW BOX, THE REMAINING SEVENTEEN WERE NOT USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139619 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT PLASTIC SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, NINETEEN OUT OF THIRTY-SIX SUTURES BROKE AT THE NEEDLE CONNECTION; NEEDLE AND SUTURE SIMPLY SEPARATED, NO FRAGMENTS WERE GENERATED. THE SURGEON TRIED MORE SUTURES FROM SAME BOX THEN EVENTUALLY OPENED A NEW BOX, THE REMAINING SEVENTEEN WERE NOT USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139618 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT PLASTIC SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, NINETEEN OUT OF THIRTY-SIX SUTURES BROKE AT THE NEEDLE CONNECTION; NEEDLE AND SUTURE SIMPLY SEPARATED, NO FRAGMENTS WERE GENERATED. THE SURGEON TRIED MORE SUTURES FROM SAME BOX THEN EVENTUALLY OPENED A NEW BOX, THE REMAINING SEVENTEEN WERE NOT USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139616 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT PLASTIC SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, NINETEEN OUT OF THIRTY-SIX SUTURES BROKE AT THE NEEDLE CONNECTION; NEEDLE AND SUTURE SIMPLY SEPARATED, NO FRAGMENTS WERE GENERATED. THE SURGEON TRIED MORE SUTURES FROM SAME BOX THEN EVENTUALLY OPENED A NEW BOX, THE REMAINING SEVENTEEN WERE NOT USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139614 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT PLASTIC SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, NINETEEN OUT OF THIRTY-SIX SUTURES BROKE AT THE NEEDLE CONNECTION; NEEDLE AND SUTURE SIMPLY SEPARATED, NO FRAGMENTS WERE GENERATED. THE SURGEON TRIED MORE SUTURES FROM SAME BOX THEN EVENTUALLY OPENED A NEW BOX, THE REMAINING SEVENTEEN WERE NOT USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139613 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT PLASTIC SURGERY ON (B)(6), 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, NINETEEN OUT OF THIRTY-SIX SUTURES BROKE AT THE NEEDLE CONNECTION; NEEDLE AND SUTURE SIMPLY SEPARATED, NO FRAGMENTS WERE GENERATED. THE SURGEON TRIED MORE SUTURES FROM SAME BOX THEN EVENTUALLY OPENED A NEW BOX, THE REMAINING SEVENTEEN WERE NOT USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139612 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT PLASTIC SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, NINETEEN OUT OF THIRTY-SIX SUTURES BROKE AT THE NEEDLE CONNECTION; NEEDLE AND SUTURE SIMPLY SEPARATED, NO FRAGMENTS WERE GENERATED. THE SURGEON TRIED MORE SUTURES FROM SAME BOX THEN EVENTUALLY OPENED A NEW BOX, THE REMAINING SEVENTEEN WERE NOT USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139610 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT PLASTIC SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, NINETEEN OUT OF THIRTY-SIX SUTURES BROKE AT THE NEEDLE CONNECTION; NEEDLE AND SUTURE SIMPLY SEPARATED, NO FRAGMENTS WERE GENERATED. THE SURGEON TRIED MORE SUTURES FROM SAME BOX THEN EVENTUALLY OPENED A NEW BOX, THE REMAINING SEVENTEEN WERE NOT USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139607 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT PLASTIC SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, NINETEEN OUT OF THIRTY-SIX SUTURES BROKE AT THE NEEDLE CONNECTION; NEEDLE AND SUTURE SIMPLY SEPARATED, NO FRAGMENTS WERE GENERATED. THE SURGEON TRIED MORE SUTURES FROM SAME BOX THEN EVENTUALLY OPENED A NEW BOX, THE REMAINING SEVENTEEN WERE NOT USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139602 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT PLASTIC SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, NINETEEN OUT OF THIRTY-SIX SUTURES BROKE AT THE NEEDLE CONNECTION; NEEDLE AND SUTURE SIMPLY SEPARATED, NO FRAGMENTS WERE GENERATED. THE SURGEON TRIED MORE SUTURES FROM SAME BOX THEN EVENTUALLY OPENED A NEW BOX, THE REMAINING SEVENTEEN WERE NOT USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139601 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT PLASTIC SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, NINETEEN OUT OF THIRTY-SIX SUTURES BROKE AT THE NEEDLE CONNECTION; NEEDLE AND SUTURE SIMPLY SEPARATED, NO FRAGMENTS WERE GENERATED. THE SURGEON TRIED MORE SUTURES FROM SAME BOX THEN EVENTUALLY OPENED A NEW BOX, THE REMAINING SEVENTEEN WERE NOT USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139598 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT PLASTIC SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, NINETEEN OUT OF THIRTY-SIX SUTURES BROKE AT THE NEEDLE CONNECTION; NEEDLE AND SUTURE SIMPLY SEPARATED, NO FRAGMENTS WERE GENERATED. THE SURGEON TRIED MORE SUTURES FROM SAME BOX THEN EVENTUALLY OPENED A NEW BOX, THE REMAINING SEVENTEEN WERE NOT USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139597 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT PLASTIC SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, NINETEEN OUT OF THIRTY-SIX SUTURES BROKE AT THE NEEDLE CONNECTION; NEEDLE AND SUTURE SIMPLY SEPARATED, NO FRAGMENTS WERE GENERATED. THE SURGEON TRIED MORE SUTURES FROM SAME BOX THEN EVENTUALLY OPENED A NEW BOX, THE REMAINING SEVENTEEN WERE NOT USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139586 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT PLASTIC SURGERY ON (B)(6) 2024, AND SUTURE WAS USED. DURING THE PROCEDURE, NINETEEN OUT OF THIRTY-SIX SUTURES BROKE AT THE NEEDLE CONNECTION; NEEDLE AND SUTURE SIMPLY SEPARATED, NO FRAGMENTS WERE GENERATED. THE SURGEON TRIED MORE SUTURES FROM SAME BOX THEN EVENTUALLY OPENED A NEW BOX, THE REMAINING SEVENTEEN WERE NOT USED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19137856 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022269. One submission often covers many models, so check the product and lot details in each record.

• Z-2144-2024 · May 10, 2024 · Open, Classified
  VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and
• Z-0989-2020 · Jan 3, 2020 · Terminated
  Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
• Z-1087-06 · May 4, 2006 · Terminated
  Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gyc