PROLENERecalls & reported problems across all models
Ethicon, LLC · 358 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one PROLENE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 7,292
- Deaths reported
- 19
- Injuries reported
- 429
- Recalls
- 2
We found 358 models of PROLENE by Ethicon, LLC in the FDA's device registry (GUDID). Together they are named in 7,292 adverse event reports in the FDA's MAUDE database, received between Dec 12, 2013 and Sep 30, 2026 — classified as 19 deaths, 429 injuries, 6,844 malfunctions.
The most frequently reported specific device problem is “Break” (3,757 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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
PROLENE 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.
- Mar 7, 2025Open, Classified
Identified curing issues with the silicone during the needles manufacturing process.
Z-1515-2025 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
- Dec 20, 2024Open, Classified
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
Z-1096-2025 · Root cause: Process control · names 5 of these models · Recall details · FDA record ↗
Most reported PROLENE problems
Device problems
- Break3,757
- Material Separation2,890
- Material Frayed315
- Adverse Event Without Identified Device or Use Problem284
- Device Markings/Labelling Problem56
- Device Contaminated During Manufacture or Shipping52
- Component Misassembled40
- Delivered as Unsterile Product40
Patient problems
- No Clinical Signs, Symptoms or Conditions5,579
- No Consequences Or Impact To Patient1,245
- Pain141
- Insufficient Information119
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available85
- Hemorrhage/Blood Loss/Bleeding84
- Not Applicable75
- Inflammation62
PROLENE models
358 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- PROLENE 8706HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 recalls294 reports
- PROLENE 8702HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 deaths254 reports
- PROLENE 8556HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death240 reports
- PROLENE 8805HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death209 reports
- PROLENE 8521HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 deaths183 reports
- PROLENE 8735HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE163 reports
- PROLENE 8711HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall89 reports
- PROLENE 9702HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE130 reports
- PROLENE EP8735HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE128 reports
- PROLENE EP8732HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE123 reports
- PROLENE 8732HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE119 reports
- PROLENE EH7585HSuture, nonabsorbable, synthetic, polypropylene1 recall63 reports
- PROLENE PMIIMesh, surgical, polymeric111 reports
- PROLENE 8557HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE109 reports
- PROLENE 8703HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE102 reports
- PROLENE EP8741HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE100 reports
- PROLENE 8522HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE99 reports
- PROLENE 8833HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall49 reports
- PROLENE 8709HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE95 reports
- PROLENE EP8755HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE89 reports
- PROLENE 8710HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE82 reports
- PROLENE EP8706HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE82 reports
- PROLENE PMHMesh, surgical, polymeric78 reports
- PROLENE M8702SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE77 reports
- PROLENE W8707Suture, nonabsorbable, synthetic, polypropylene75 reports
- PROLENE 8695GSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE72 reports
- PROLENE 8935HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall21 reports
- PROLENE 8720HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE70 reports
- PROLENE M8703SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE70 reports
- PROLENE W8704Suture, nonabsorbable, synthetic, polypropylene64 reports
- PROLENE 8523HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE63 reports
- PROLENE HS6855HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE61 reports
- PROLENE 8425HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE57 reports
- PROLENE EP8702HSuture, nonabsorbable, synthetic, polypropylene56 reports
- PROLENE PMLMesh, surgical, polymeric55 reports
- PROLENE EP8747HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE54 reports
- PROLENE M8557SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE52 reports
- PROLENE HS6861HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE52 reports
- PROLENE EPM8735SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death51 reports
- PROLENE 8411HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE50 reports
- PROLENE 8534HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death50 reports
- PROLENE 8963HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall0 reports
- PROLENE W8304Suture, nonabsorbable, synthetic, polypropylene50 reports
- PROLENE 8741HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE49 reports
- PROLENE EP8704SLHSuture, nonabsorbable, synthetic, polypropylene49 reports
- PROLENE 8726HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death47 reports
- PROLENE 8707HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE45 reports
- PROLENE M8706SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE44 reports
- PROLENE 8423HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE42 reports
- PROLENE HS6857HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE42 reports
- PROLENE EH7222HSuture, nonabsorbable, synthetic, polypropylene41 reports
- PROLENE EPM8739SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE41 reports
- PROLENE M8805SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death39 reports
- PROLENE 8556GSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE38 reports
- PROLENE EPM8702SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE37 reports
- PROLENE W2777Suture, nonabsorbable, synthetic, polypropylene36 reports
- PROLENE EPM8755SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE36 reports
- PROLENE EP8730HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE36 reports
- PROLENE 8704HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE35 reports
- PROLENE W8761GSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE35 reports
- PROLENE 8610HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE34 reports
- PROLENE 8807HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE34 reports
- PROLENE EP8709HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE34 reports
- PROLENE 8307HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE33 reports
- PROLENE 8725HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE33 reports
- PROLENE M8709SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE33 reports
- PROLENE EP8805HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE33 reports
- PROLENE 8696GSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE32 reports
- PROLENE W8703Suture, nonabsorbable, synthetic, polypropylene32 reports
- PROLENE EPM8743SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE32 reports
- PROLENE 8424HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE30 reports
- PROLENE EPH7477HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE30 reports
- PROLENE 8683GSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE29 reports
- PROLENE 8806HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE29 reports
- PROLENE EPM8703SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE29 reports
- PROLENE EP8704HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE29 reports
- PROLENE 8526HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE28 reports
- PROLENE 8718HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE28 reports
- PROLENE EPM8733SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE28 reports
- PROLENE W8807SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE27 reports
- PROLENE EPH8720HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE27 reports
- PROLENE EP8703HSuture, nonabsorbable, synthetic, polypropylene26 reports
- PROLENE 8776HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death25 reports
- PROLENE EPM8745SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE25 reports
- PROLENE 8205HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE24 reports
- PROLENE EP8740HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE24 reports
- PROLENE EPH8710HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE24 reports
- PROLENE 8554HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE23 reports
- PROLENE M8725SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE23 reports
- PROLENE W295HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE23 reports
- PROLENE 8581HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death22 reports
- PROLENE M8726SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE22 reports
- PROLENE HS6856HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE22 reports
- PROLENE 8412HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE21 reports
- PROLENE SPMHMesh, surgical, polymeric21 reports
- PROLENE 8730HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE20 reports
- PROLENE 8747HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE20 reports
- PROLENE 8834HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE20 reports
- PROLENE EPM8747SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE20 reports
- PROLENE EPM8706SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE20 reports
Recent PROLENE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951521 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951520 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951518 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951517 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951516 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951515 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950505 ↗MalfunctionSep 30, 2026Break
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. After suturing the blood vessel, the thread broke directly at the final knot. There were no adverse patient consequences reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950500 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950499 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950494 ↗MalfunctionSep 30, 2026Break
It was reported that a patient underwent a aortic revision procedure on (b)(6)2026 and suture was used. During surgery (vascular procedure) the subject sutures were used, among other products. According to the surgeon, while suturing the anastomotic line, after several passes through the tissue, two of the sutures in use were torn in the middle section of the suture strand, and a third suture was torn in proximity to the needle attachment area, also after several passes through the tissue. It was further reported that a fourth suture may also have torn; however, the surgeon could not recall the details. The surgeon noted that the tissue was hard. All sutures that were torn originated from the same package. It should be noted that, according to the report, one or two additional sutures from the same package were used during the same procedure without a similar event occurring. The procedure was completed successfully, and there was no patient harm. No adverse patient consequences were reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949992 ↗MalfunctionSep 30, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949986 ↗MalfunctionSep 30, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949975 ↗MalfunctionSep 30, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949961 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949724 ↗
Other Ethicon, LLC products
- Coated VICRYL350 models · 8,555 reports · 1 recall
- STRATAFIX181 models · 7,673 reports · 7 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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