Coated VICRYL J548GRecalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10705031041134), received between Jun 25, 2020 and Aug 25, 2026 — classified as 10 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50441740 ↗
• MalfunctionApr 28, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED ON (B)(6) 2026 THAT FOREIGN BODY EG PLASTIC OR GLUE (DRIED) COATING LARGE PORTION OF NEEDLE SURFACE. UNUSABLE AND COULD HAVE BEEN ACCIDENTLY RETAINED IN PATIENT (ANTERIOR CHAMBER OR UNDER SCLERA CONJUNCTIVA). NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020707 ↗
• MalfunctionMar 31, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPHTHALMIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN OPHTHALMOLOGY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS OCCURRED WITH 2 SUTURES IN A ROW. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743167 ↗
• MalfunctionMar 31, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPHTHALMIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN OPHTHALMOLOGY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS OCCURRED WITH 2 SUTURES IN A ROW. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743149 ↗
• MalfunctionMar 31, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPHTHALMIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN OPHTHALMOLOGY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS OCCURRED WITH 2 SUTURES IN A ROW. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743101 ↗
• MalfunctionMar 31, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPHTHALMIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN OPHTHALMOLOGY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT OCCURRED WITH 2 SUTURES IN A ROW. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743087 ↗
• MalfunctionMar 31, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPHTHALMIC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN OPHTHALMOLOGY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS OCCURRED WITH 2 SUTURES IN A ROW. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743066 ↗
• MalfunctionFeb 27, 2026Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472093 ↗
• MalfunctionFeb 27, 2026Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472079 ↗
• MalfunctionFeb 27, 2026Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472072 ↗
• MalfunctionFeb 27, 2026Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472051 ↗
• MalfunctionFeb 27, 2026Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472016 ↗
• MalfunctionFeb 27, 2026Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472015 ↗
• MalfunctionFeb 27, 2026Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472001 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT DURING AN UNKNOWN PROCEDURE THE SUTURES KEPT BREAKING. SURGEON SWITCHED TO A DIFFERENT LOT AND THEY WORKED WELL. NO OTHER DETAILS PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270931 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT DURING AN UNKNOWN PROCEDURE THE SUTURES KEPT BREAKING. SURGEON SWITCHED TO A DIFFERENT LOT AND THEY WORKED WELL. NO OTHER DETAILS PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270833 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR THAT DURING AN UNKNOWN PROCEDURE THE SUTURES KEPT BREAKING. SURGEON SWITCHED TO A DIFFERENT LOT AND THEY WORKED WELL. NO OTHER DETAILS PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270810 ↗
• MalfunctionNov 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE AND SUTURE WAS DETACHED WHILE SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632656 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. ALL OF THE SUTURES BROKE (THE KNOTS DID NOT UNTIE) OS DURING THE 24HR RECHECK AT OUR HOSPITAL DURING EXAM. THESE WERE REPLACED WITH 8-0 VICRYL SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279810 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN ANIMAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. ALL OF THE SUTURES BROKE (THE KNOTS DID NOT UNTIE) OS DURING THE 24HR RECHECK AT OUR HOSPITAL DURING EXAM. THESE WERE REPLACED WITH 8-0 VICRYL SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279730 ↗
• MalfunctionSep 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLES CAME AWAY FROM THE THREADS AFTER PASSING THROUGH TISSUE WHEN THE SURGEON PULLED ON NEEDLE TO DRAW THREAD THROUGH AND THREAD BROKE WHEN THE SURGEON WAS TYING THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039806 ↗
• MalfunctionSep 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLES CAME AWAY FROM THE THREADS AFTER PASSING THROUGH TISSUE WHEN THE SURGEON PULLED ON NEEDLE TO DRAW THREAD THROUGH AND THREAD BROKE WHEN THE SURGEON WAS TYING THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039803 ↗
• MalfunctionSep 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLES CAME AWAY FROM THE THREADS AFTER PASSING THROUGH TISSUE WHEN THE SURGEON PULLED ON NEEDLE TO DRAW THREAD THROUGH AND THREAD BROKE WHEN THE SURGEON WAS TYING THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039798 ↗
• MalfunctionAug 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN SURGEON WANT USE SUTURE THREAD WAS BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922594 ↗
• MalfunctionAug 7, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, IT WAS FOUND THAT IT LOOKED LIKE POWDERY WHEN THE PACKAGE WAS OPENED AND CHECKED IT BEFORE USE. THE CUSTOMER WANT TO KNOW IF THERE WAS THE CASE. THIS EVENT WAS FOUND BEFORE USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738263 ↗

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