Coated VICRYLRecalls & reported problems across all models
Ethicon, LLC · 350 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Coated VICRYL model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 8,555
- Deaths reported
- 3
- Injuries reported
- 596
- Recalls
- 1
We found 350 models of Coated VICRYL by Ethicon, LLC in the FDA's device registry (GUDID). Together they are named in 8,555 adverse event reports in the FDA's MAUDE database, received between Sep 22, 2017 and Sep 30, 2026 — classified as 3 deaths, 596 injuries, 7,956 malfunctions.
The most frequently reported specific device problem is “Material Separation” (4,496 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Coated 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.
- May 10, 2024Open, Classified
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Z-2145-2024 · Root cause: Under Investigation by firm · names 4 of these models · Recall details · FDA record ↗
Most reported Coated VICRYL problems
Device problems
- Material Separation4,496
- Break2,988
- Adverse Event Without Identified Device or Use Problem383
- Material Frayed204
- Material Integrity Problem117
- Device Contaminated During Manufacture or Shipping109
- Device Markings/Labelling Problem80
- Appropriate Device Problem Term/Code Not Available78
Patient problems
- No Clinical Signs, Symptoms or Conditions6,776
- No Consequences Or Impact To Patient1,064
- Inflammation170
- Wound Dehiscence169
- Unspecified Infection142
- Impaired Healing103
- Not Applicable103
- Insufficient Information98
Coated VICRYL models
350 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Coated VICRYL VCP433HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death1,093 reports
- Coated VICRYL VCP493HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID435 reports
- Coated VICRYL VCP345HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death405 reports
- Coated VICRYL J433HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID255 reports
- Coated VICRYL VCP311HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID252 reports
- Coated VICRYL VCP213HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID244 reports
- Coated VICRYL J570GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID170 reports
- Coated VICRYL VCP602HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID156 reports
- Coated VICRYL J258HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID155 reports
- Coated VICRYL J947HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID139 reports
- Coated VICRYL VCPB840DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID139 reports
- Coated VICRYL VCP603HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall82 reports
- Coated VICRYL VCPB725DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID120 reports
- Coated VICRYL VCP303HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID118 reports
- Coated VICRYL VCP371HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID117 reports
- Coated VICRYL VCP772DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID104 reports
- Coated VICRYL VCP417HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall48 reports
- Coated VICRYL VCP304HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID96 reports
- Coated VICRYL VCPB946HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall43 reports
- Coated VICRYL J494GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID86 reports
- Coated VICRYL JB840SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID81 reports
- Coated VICRYL J603HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID80 reports
- Coated VICRYL J602HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID76 reports
- Coated VICRYL VCP771DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID72 reports
- Coated VICRYL J311HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID71 reports
- Coated VICRYL VCP500HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID70 reports
- Coated VICRYL VCP752DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death70 reports
- Coated VICRYL J490GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID67 reports
- Coated VICRYL VCP945HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID66 reports
- Coated VICRYL J493GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID63 reports
- Coated VICRYL J304HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID62 reports
- Coated VICRYL J416HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID60 reports
- Coated VICRYL J772DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID58 reports
- Coated VICRYL VCP434HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID54 reports
- Coated VICRYL VCP196HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall0 reports
- Coated VICRYL J443HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID49 reports
- Coated VICRYL J495GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID48 reports
- Coated VICRYL VCP341HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID48 reports
- Coated VICRYL J548GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID47 reports
- Coated VICRYL VCP352HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID47 reports
- Coated VICRYL VCP663HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID47 reports
- Coated VICRYL J556GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID45 reports
- Coated VICRYL JB841SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID44 reports
- Coated VICRYL VCPB945HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID44 reports
- Coated VICRYL J434HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID42 reports
- Coated VICRYL J496GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID41 reports
- Coated VICRYL J442HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID39 reports
- Coated VICRYL J499GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID39 reports
- Coated VICRYL J566GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID39 reports
- Coated VICRYL J555GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID38 reports
- Coated VICRYL VCP946HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID38 reports
- Coated VICRYL J422HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID36 reports
- Coated VICRYL VCP460HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID36 reports
- Coated VICRYL VCP486HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID36 reports
- Coated VICRYL J386HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID35 reports
- Coated VICRYL J546GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID33 reports
- Coated VICRYL J774DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID33 reports
- Coated VICRYL VCP339HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID33 reports
- Coated VICRYL VCP493GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID33 reports
- Coated VICRYL J305HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID32 reports
- Coated VICRYL VCP494GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID32 reports
- Coated VICRYL VCP493HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID32 reports
- Coated VICRYL VCP714DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID31 reports
- Coated VICRYL J215HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID30 reports
- Coated VICRYL VCPB864DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID30 reports
- Coated VICRYL J318HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID29 reports
- Coated VICRYL J207GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID28 reports
- Coated VICRYL J426HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID28 reports
- Coated VICRYL J740DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID28 reports
- Coated VICRYL VCP451HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID28 reports
- Coated VICRYL VCP500GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID28 reports
- Coated VICRYL J214HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID27 reports
- Coated VICRYL J310HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID26 reports
- Coated VICRYL VCPB977HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID26 reports
- Coated VICRYL VCPP41DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID26 reports
- Coated VICRYL J259HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID25 reports
- Coated VICRYL J771DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID25 reports
- Coated VICRYL JB724SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID25 reports
- Coated VICRYL VCP751DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID25 reports
- Coated VICRYL J506GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID24 reports
- Coated VICRYL VCP219HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID24 reports
- Coated VICRYL VCP333HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID24 reports
- Coated VICRYL VCP340HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID24 reports
- Coated VICRYL VCP753DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID24 reports
- Coated VICRYL J421HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID23 reports
- Coated VICRYL VCP305HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID23 reports
- Coated VICRYL VCP519HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID23 reports
- Coated VICRYL VCPB839DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID23 reports
- Coated VICRYL VCP589HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID22 reports
- Coated VICRYL VCPB340HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID22 reports
- Coated VICRYL JJ41GSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID21 reports
- Coated VICRYL VCP518HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID21 reports
- Coated VICRYL VCP743DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID21 reports
- Coated VICRYL J864DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID20 reports
- Coated VICRYL J303HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID20 reports
- Coated VICRYL VCPP81DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID20 reports
- Coated VICRYL VCP458HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID19 reports
- Coated VICRYL VCP713DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID19 reports
- Coated VICRYL VCP784DSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID19 reports
- Coated VICRYL VCP823HSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID19 reports
Recent Coated VICRYL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949539 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948225 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948186 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948167 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947929 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947917 ↗MalfunctionSep 30, 2026Break
It was reported a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. When opening the package, the wire was broken, during the procedure before use.Upon receipt and analysis, a short insertion was noted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946712 ↗MalfunctionSep 30, 2026Break
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. The suture was broken during use. It was not a control release needle. Another product was used to complete the case. No adverse patient consequences were reported. Additional information was requested
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946248 ↗MalfunctionSep 30, 2026Material Separation
It was reported that a patient underwent a Tumor Resection procedure on (b)(6) 2026 and suture was used. At 9:45, the patient had surgery due to lip tumor. When suturing with suture during surgery, the problem of pulling off suture needle happened, and the same batch of surgical suture was immediately replaced to complete the subsequent surgery. Extended the surgery time. No adverse patient consequences were reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944788 ↗MalfunctionSep 29, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938095 ↗MalfunctionSep 29, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938046 ↗MalfunctionSep 29, 2026Material Separation
It was reported that a patient underwent an unknown laparoscopic procedure on an unknown date and suture was used. During surgery, the suture was detached from the needle when the suture was placed at the umbilical port insertion site. Apparently, it came off without any force being applied. It was not a control release needle. Additional suture was performed to complete the case. No adverse patient consequences were reported. Additional information was requested
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934365 ↗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 ↗
Other Ethicon, LLC products
- 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
- PERMA-HAND77 models · 664 reports · 1 recall
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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