VICRYLRecalls & reported problems across all models
Ethicon, LLC · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 157
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 1
We found 7 models of VICRYL by Ethicon, LLC in the FDA's device registry (GUDID). Together they are named in 157 adverse event reports in the FDA's MAUDE database, received between Mar 3, 2017 and Sep 25, 2026 — classified as 5 injuries, 151 malfunctions.
The most frequently reported specific device problem is “Material Separation” (107 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
VICRYL recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 9, 2020Terminated
Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. The correct VICRYL suture is size 10-0, 4 inches (10 cm) in length, has monofilament construction, and a single needle. The incorrect VICRYL suture is size 6-0, 18 inches (45 cm) in length, has braided construction, and two needles
Z-0116-2021 · Root cause: Packaging process control · Recall details · FDA record ↗
Most reported VICRYL problems
Device problems
- Material Separation107
- Break50
- Appropriate Device Problem Term/Code Not Available6
- Device Markings/Labelling Problem3
- Dull, Blunt2
- Defective Device1
- Delivered as Unsterile Product1
- Detachment Of Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions137
- No Consequences Or Impact To Patient19
- Anxiety5
- Hemorrhage/Blood Loss/Bleeding5
- Insufficient Information5
- No Known Impact Or Consequence To Patient1
VICRYL models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VICRYL V960GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall55 reports
- VICRYL V449GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID74 reports
- VICRYL V450GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID15 reports
- VICRYL V448GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID7 reports
- VICRYL D8760SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- VICRYL D5792SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID2 reports
- VICRYL D7498SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
Recent VICRYL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Break
It was reported that a patient underwent a caesarean section procedure on an unknown date and suture was used. During the procedure the suture in question was used, among other products, during the uterine closure. The surgeon made the initial pass of the needle and suture through the tissue and formed an initial knot manually. While tightening the knot on the uterine tissue, the suture tore in an area close to the uterine tissue. Because the suture is long, the surgeon passed the same needle with the suture again, formed another knot manually, and tightened it, and continued the suturing without a similar issue and completed the procedure successfully. No adverse patient consequences were reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897944 ↗MalfunctionSep 25, 2026Break
It was reported that a patient underwent a caesarean section procedure on an unknown date and suture was used. During the procedure the suture in question was used, among other products, during the uterine closure. The surgeon made the initial pass of the needle and suture through the tissue and formed an initial knot manually. While tightening the knot on the uterine tissue, the suture tore in an area close to the uterine tissue. Because the suture is long, the surgeon passed the same needle with the suture again, formed another knot manually, and tightened it, and continued the suturing without a similar issue and completed the procedure successfully. No adverse patient consequences were reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897569 ↗MalfunctionAug 12, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50222362 ↗MalfunctionAug 5, 2026Break; Dull, Blunt
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50142194 ↗MalfunctionAug 5, 2026Break; Dull, Blunt
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50142182 ↗MalfunctionMay 4, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE NEEDLE AND THREAD SEPARATION OCCURRED WHEN THE CUSTOMER USED THIS PRODUCT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25069524 ↗MalfunctionApr 14, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A CATARACT SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. DURING A CATARACT SURGERY, THE NEEDLE FELL OFF THE SUTURE AND THEY HAD TO OPEN A 2ND PACK TO FINISH SURGERY. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24873148 ↗MalfunctionApr 14, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING AN OPHTHALMOLOGY SURGERY, THEY OPENED 3 PACKS OF SUTURE, AND THE NEEDLE FELL OFF THE SUTURE ON ALL 3 OF THEM. PATIENT WAS NOT HARMED BUT THEY DID HAVE TO OPEN A 4TH PACK TO COMPLETE SURGERY AND THE OTHER 3 PACKS OPENED WERE UNUSABLE. DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24871900 ↗MalfunctionApr 14, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING AN OPHTHALMOLOGY SURGERY, THEY OPENED 3 PACKS OF SUTURE, AND THE NEEDLE FELL OFF THE SUTURE ON ALL 3 OF THEM. PATIENT WAS NOT HARMED BUT THEY DID HAVE TO OPEN A 4TH PACK TO COMPLETE SURGERY AND THE OTHER 3 PACKS OPENED WERE UNUSABLE. DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24871870 ↗MalfunctionApr 14, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING AN OPHTHALMOLOGY SURGERY, THEY OPENED 3 PACKS OF SUTURE, AND THE NEEDLE FELL OFF THE SUTURE ON ALL 3 OF THEM. PATIENT WAS NOT HARMED BUT THEY DID HAVE TO OPEN A 4TH PACK TO COMPLETE SURGERY AND THE OTHER 3 PACKS OPENED WERE UNUSABLE. DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24871866 ↗MalfunctionApr 3, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN VETERINARY SURGERY, THE SUTURE WAS BROKEN DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24775213 ↗MalfunctionApr 3, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN VETERINARY SURGERY, THE SUTURE WAS BROKEN DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24775211 ↗MalfunctionApr 1, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN VETERINARY SURGERY, THE SUTURE WAS BROKEN DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24757968 ↗MalfunctionApr 1, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN VETERINARY SURGERY, THE SUTURE WAS BROKEN DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24757958 ↗MalfunctionApr 1, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN VETERINARY SURGERY, THE SUTURE WAS BROKEN DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24757954 ↗
Other Ethicon, LLC products
- Coated VICRYL350 models · 8,555 reports · 1 recall
- STRATAFIX181 models · 7,673 reports · 7 recalls
- PROLENE358 models · 7,292 reports · 2 recalls
- PDS224 models · 2,635 reports · 10 recalls
- MONOCRYL127 models · 2,308 reports · 3 recalls
- ETHILON133 models · 1,680 reports · 1 recall
- DERMABOND PRINEO4 models · 1,099 reports
- ETHIBOND EXCEL134 models · 921 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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