Coated VICRYL J496GRecalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10705031040588), received between May 14, 2019 and Sep 29, 2026 — classified as 20 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (13 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933885 ↗
• MalfunctionSep 29, 2026Material Separation

  It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. Four needles pop off suture. No delay was reported. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933817 ↗
• MalfunctionSep 29, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933805 ↗
• MalfunctionSep 29, 2026Material Separation

  It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. Four needles pop off suture. No delay was reported. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933769 ↗
• MalfunctionOct 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE CAME OFF OF THE SUTURE WHEN REPAIRING A LACERATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20537998 ↗
• MalfunctionMar 20, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. THE PROVIDER WAS PLACING SUTURES ON PATIENT AND THE NEEDLE BROKE OFF THE STRING AS SOON AS SHE PUT IT INTO/THROUGH THE SKIN. THE PROVIDER HAD TO PUSH THE PUNCH TOOL BACK INTO THE SPOT TO GET THE NEEDLE TO REMOVE IT. A NEW SUTURE WAS OPENED AND THE NEEDLE BROKE OFF THE STRING AGAIN. PROVIDER USED THE SAME TECHNIQUE TO REMOVE THE NEEDLE. LOT NUMBERS WERE FOUND TO BE THE SAME. THEY FOUND A NEW SUTURE WITH A DIFFERENT LOT WITHOUT ISSUE. THERE WAS NO HARM TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18939118 ↗
• MalfunctionMar 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024, AND SUTURE WAS USED. THE PROVIDER WAS PLACING SUTURES ON PATIENT AND THE NEEDLE BROKE OFF THE STRING AS SOON AS SHE PUT IT INTO/THROUGH THE SKIN. THE PROVIDER HAD TO PUSH THE PUNCH TOOL BACK INTO THE SPOT TO GET THE NEEDLE TO REMOVE IT. A NEW SUTURE WAS OPENED AND THE NEEDLE BROKE OFF THE STRING AGAIN. PROVIDER USED THE SAME TECHNIQUE TO REMOVE THE NEEDLE. LOT NUMBERS WERE FOUND TO BE THE SAME. THEY FOUND A NEW SUTURE WITH A DIFFERENT LOT WITHOUT ISSUE. THERE WAS NO HARM TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18914002 ↗
• MalfunctionNov 13, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR ¿OUR CUSTOMER HAS BROUGHT TO OUR ATTENTION THAT THESE TWO SUTURES, WERE BREAKING WHEN USED. CUSTOMER STATES THAT THEY HAVE BEEN USING THIS BRAND FOR 10 YEARS AND THIS HAS NEVER HAPPENED BEFORE.¿ IT IS UNKNOWN IF THERE ANY PATIENT CONSEQUENCES. THE DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18124187 ↗
• MalfunctionSep 28, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING A GYN SURGERY WITH CLOSURE OF WOUND, WHILE SUTURING PATIENT IN SURGERY, SUTURE NEEDLE WAS NOTED TO BE 2-3 MM MISSING THE TIP WHEN COMPARED TO ANOTHER NEEDLE. WOUND WAS EXAMINED, FLOOR EXAMINED AND TABLE INSPECTED WITH NO TIP OF NEEDLE FOUND. AN X-RAY OF THE ABDOMEN WAS ORDER ON THE PATIENT WHICH RESULTED WITH NO NEEDLE TIP FOUND IN PATIENT. GUIDELINES FOLLOWED. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17834912 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC APPENDICECTOMY FOR ACUTE APPENDICITIS WITH SUDDEN CHILLS, EPIGASTRALGIA, AND NAUSEA ON AN UNKNOWN DATE AND SUTURE WAS USED FOR HEMOSTASIS BY Z-SHAPED SUTURE FOR ARTERIAL AND VENOUS BLEEDING THAT FORMED A HEMATOMA. POSTOPERATIVELY, THE PATIENT HAD PAIN IN THE AREA OF HEMATOMA FORMATION IN THE LOWER ABDOMEN, BUT DRAIN DRAINAGE WAS PALE BLOOD AND VITAL SIGNS WERE STABLE, SO THE PATIENT WAS STARTED ON ORAL INTAKE 2 DAYS AFTER SURGERY AND THE DRAIN WAS REMOVED. SEVEN DAYS AFTER SURGERY, PAIN AT THE SITE OF HEMATOMA FORMATION WORSENED. ALTHOUGH NO PROGRESSION OF ANEMIA WAS OBSERVED, AN INCREASE IN CRP LEVELS WAS NOTED. CT AND IVR REVEALED A PSEUDOANEURYSM, AND A MICROCOIL WAS PLACED TO CONFIRM HEMOSTASIS. AFTER THE TREATMENT WAS DONE, THE PATIENT'S ABDOMINAL SYMPTOMS GRADUALLY IMPROVED, AND ON POSTOPERATIVE DAY 14, A CT SCAN CONFIRMED THAT THE HEMATOMA HAD NOT INCREASED. FIFTEEN DAYS AFTER SURGERY, THE PATIENT WAS DISCHARGED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hematoma; Pain; Pseudoaneurysm

  MAUDE report 16820254 ↗
• MalfunctionDec 27, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY THE CUSTOMER THAT IN THE RECEIVING DEPARTMENT, THEY DISCOVERED THAT ITEM LOT NUMBER MISMATCHED OF ITEM J496G. WHEN ENTERING INTO THEIR SYSTEM, LOT NUMBER ON THE ITEM IS SLMHUU WITH AN EXPIRATION OF 9/30/2027, BUT THE PACKING SLIP AND INVOICE ITEM SHOW LOT NUMBER AS SKMKLK WITH AN EXPIRATION DATE OF 8/31/2027, WHICH IS THE CORRECT EXPIRATION DATE APPEARING ON THE INVOICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16051313 ↗
• MalfunctionDec 27, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY THE CUSTOMER THAT IN THE RECEIVING DEPARTMENT, THEY DISCOVERED THAT ITEM LOT NUMBER MISMATCHED OF ITEM J496G. WHEN ENTERING INTO THEIR SYSTEM, LOT NUMBER ON THE ITEM IS SLMHUU WITH AN EXPIRATION OF 9/30/2027, BUT THE PACKING SLIP AND INVOICE ITEM SHOW LOT NUMBER AS SKMKLK WITH AN EXPIRATION DATE OF 8/31/2027, WHICH IS THE CORRECT EXPIRATION DATE APPEARING ON THE INVOICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16051310 ↗
• MalfunctionDec 27, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY THE CUSTOMER THAT IN THE RECEIVING DEPARTMENT, THEY DISCOVERED THAT ITEM LOT NUMBER MISMATCHED OF ITEM J496G. WHEN ENTERING INTO THEIR SYSTEM, LOT NUMBER ON THE ITEM IS SLMHUU WITH AN EXPIRATION OF 9/30/2027, BUT THE PACKING SLIP AND INVOICE ITEM SHOW LOT NUMBER AS SKMKLK WITH AN EXPIRATION DATE OF 8/31/2027, WHICH IS THE CORRECT EXPIRATION DATE APPEARING ON THE INVOICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16051309 ↗
• MalfunctionDec 27, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY THE CUSTOMER THAT IN THE RECEIVING DEPARTMENT, THEY DISCOVERED THAT ITEM LOT NUMBER MISMATCHED OF ITEM J496G. WHEN ENTERING INTO THEIR SYSTEM, LOT NUMBER ON THE ITEM IS SLMHUU WITH AN EXPIRATION OF 9/30/2027, BUT THE PACKING SLIP AND INVOICE ITEM SHOW LOT NUMBER AS SKMKLK WITH AN EXPIRATION DATE OF 8/31/2027, WHICH IS THE CORRECT EXPIRATION DATE APPEARING ON THE INVOICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16051308 ↗
• InjuryMar 4, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT THAT HAD THE COVID VACCINE EXPERIENCED A REACTION LIKE DERMATITIS BECAUSE THE SUTURE WAS NOT DISSOLVING. THE HCP REFERRED THIS TO A "SPITTING SUTURE". NO HOSPITALIZATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Skin Inflammation/ Irritation

  MAUDE report 13677524 ↗
• InjuryMar 4, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT THAT HAD THE COVID VACCINE EXPERIENCED A REACTION LIKE DERMATITIS BECAUSE THE SUTURE WAS NOT DISSOLVING. THE HCP REFERRED THIS TO A "SPITTING SUTURE". NO HOSPITALIZATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Skin Inflammation/ Irritation

  MAUDE report 13677516 ↗
• InjuryMar 4, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT THAT HAD THE COVID VACCINE EXPERIENCED A REACTION LIKE DERMATITIS BECAUSE THE SUTURE WAS NOT DISSOLVING. THE HCP REFERRED THIS TO A "SPITTING SUTURE". NO HOSPITALIZATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Skin Inflammation/ Irritation

  MAUDE report 13677509 ↗
• InjuryMar 4, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT THAT HAD THE COVID VACCINE EXPERIENCED A REACTION LIKE DERMATITIS BECAUSE THE SUTURE WAS NOT DISSOLVING. THE HCP REFERRED THIS TO A "SPITTING SUTURE". NO HOSPITALIZATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Skin Inflammation/ Irritation

  MAUDE report 13677501 ↗
• InjuryMar 4, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT THAT HAD THE COVID VACCINE EXPERIENCED A REACTION LIKE DERMATITIS BECAUSE THE SUTURE WAS NOT DISSOLVING. THE HCP REFERRED THIS TO A "SPITTING SUTURE". NO HOSPITALIZATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Skin Inflammation/ Irritation

  MAUDE report 13677459 ↗
• InjuryMar 4, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT THAT HAD THE COVID VACCINE EXPERIENCED A REACTION LIKE DERMATITIS BECAUSE THE SUTURE WAS NOT DISSOLVING. THE HCP REFERRED THIS TO A "SPITTING SUTURE". NO HOSPITALIZATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Skin Inflammation/ Irritation

  MAUDE report 13677442 ↗
• InjuryMar 4, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT THAT HAD THE COVID VACCINE EXPERIENCED A REACTION LIKE DERMATITIS BECAUSE THE SUTURE WAS NOT DISSOLVING. THE HCP REFERRED THIS TO A "SPITTING SUTURE". NO HOSPITALIZATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Skin Inflammation/ Irritation

  MAUDE report 13677441 ↗
• InjuryMar 4, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT THAT HAD THE COVID VACCINE EXPERIENCED A REACTION LIKE DERMATITIS BECAUSE THE SUTURE WAS NOT DISSOLVING. THE HCP REFERRED THIS TO A "SPITTING SUTURE". NO HOSPITALIZATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Skin Inflammation/ Irritation

  MAUDE report 13677364 ↗
• InjuryMar 4, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT THAT HAD THE COVID VACCINE EXPERIENCED A REACTION LIKE DERMATITIS BECAUSE THE SUTURE WAS NOT DISSOLVING. THE HCP REFERRED THIS TO A "SPITTING SUTURE". NO HOSPITALIZATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Skin Inflammation/ Irritation

  MAUDE report 13677350 ↗
• InjuryMar 4, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT THAT HAD THE COVID VACCINE EXPERIENCED A REACTION LIKE DERMATITIS BECAUSE THE SUTURE WAS NOT DISSOLVING. THE HCP REFERRED THIS TO A "SPITTING SUTURE". NO HOSPITALIZATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Skin Inflammation/ Irritation

  MAUDE report 13677320 ↗
• InjuryMar 4, 2022Material Integrity Problem; Material Integrity Problem

  HOLD FOR EM 4.6.2022IT WAS REPORTED THAT A PATIENT THAT HAD THE COVID VACCINE EXPERIENCED A REACTION LIKE DERMATITIS BECAUSE THE SUTURE WAS NOT DISSOLVING. THE HCP REFERRED THIS TO A "SPITTING SUTURE". NO HOSPITALIZATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Skin Inflammation/ Irritation

  MAUDE report 13677303 ↗

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