MERSILENERecalls & reported problems across all models

We found 12 models of MERSILENE by Ethicon, LLC in the FDA's device registry (GUDID). Together they are named in 97 adverse event reports in the FDA's MAUDE database, received between Mar 12, 2018 and Sep 9, 2026 — classified as 10 injuries, 87 malfunctions.

The most frequently reported specific device problem is “Material Separation” (54 reports).

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

Most reported MERSILENE problems

MERSILENE models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MERSILENE RS22

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  49 reports
• MERSILENE RS23

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  14 reports
• MERSILENE 1779G

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  8 reports
• MERSILENE 1764G

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  7 reports
• MERSILENE D9212

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  6 reports
• MERSILENE R691G

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  4 reports
• MERSILENE RS21

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  4 reports
• MERSILENE 1722G

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  1 report
• MERSILENE 746G

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  1 report
• MERSILENE R647H

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  1 report
• MERSILENE R665H

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  1 report
• MERSILENE R952H

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  1 report

Recent MERSILENE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699100 ↗
• MalfunctionSep 9, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699097 ↗
• MalfunctionAug 19, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50331726 ↗
• MalfunctionMay 27, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE SURGEON TO THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, THE NEEDLE POPPED RIGHT OFF WITH MINIMAL TENSION AND IT HAPPENED TWICE ON THE SAME PROCEDURE. NO PATIENT CONSEQUENCES. DEVICE WILL BE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299144 ↗
• MalfunctionMay 27, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE SURGEON TO THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, THE NEEDLE POPPED RIGHT OFF WITH MINIMAL TENSION AND IT HAPPENED TWICE ON THE SAME PROCEDURE. NO PATIENT CONSEQUENCES. DEVICE WILL BE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299142 ↗
• MalfunctionApr 29, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CERCLAGE PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT TO THE SALES REP THAT DURING A CERCLAGE PROCEDURE, THE NEEDLES COMING OFF TOO EASILY. NO PATIENT CONSEQUENCES. DEVICE WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033308 ↗
• MalfunctionFeb 6, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE AHS THAT DURING A CERCLAGE PROCEDURE, WHEN NURSE LOADED SUTURE, THE WHITE SUTURE MATERIAL ATTACHED TO THE NEEDLE CAME APART. THE NEEDLE AND THE WHITE SUTURE MATERIAL WERE SEPARATED. THE ISSUE OCCURRED MULTIPLE TIMES. NO OTHER DETAILS PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279844 ↗
• MalfunctionFeb 6, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE AHS THAT DURING A CERCLAGE PROCEDURE, WHEN NURSE LOADED SUTURE, THE WHITE SUTURE MATERIAL ATTACHED TO THE NEEDLE CAME APART. THE NEEDLE AND THE WHITE SUTURE MATERIAL WERE SEPARATED. THE ISSUE OCCURRED MULTIPLE TIMES. NO OTHER DETAILS PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279843 ↗
• MalfunctionFeb 6, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE AHS THAT DURING A CERCLAGE PROCEDURE, WHEN NURSE LOADED SUTURE, THE WHITE SUTURE MATERIAL ATTACHED TO THE NEEDLE CAME APART. THE NEEDLE AND THE WHITE SUTURE MATERIAL WERE SEPARATED. THE ISSUE OCCURRED MULTIPLE TIMES. NO OTHER DETAILS PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279836 ↗
• MalfunctionFeb 2, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CERCLAGE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE AHS THAT DURING A CERCLAGE PROCEDURE, WHEN NURSE LOADED SUTURE, THE WHITE SUTURE MATERIAL ATTACHED TO THE NEEDLE CAME APART. THE NEEDLE AND THE WHITE SUTURE MATERIAL WERE SEPARATED. THE ISSUE OCCURRED MULTIPLE TIMES. NO OTHER DETAILS PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234801 ↗
• MalfunctionFeb 2, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CERCLAGE PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE AHS THAT DURING A CERCLAGE PROCEDURE, WHEN NURSE LOADED SUTURE, THE WHITE SUTURE MATERIAL ATTACHED TO THE NEEDLE CAME APART. THE NEEDLE AND THE WHITE SUTURE MATERIAL WERE SEPARATED. THE ISSUE OCCURRED MULTIPLE TIMES. NO OTHER DETAILS PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234380 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24072257 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24072251 ↗
• MalfunctionJan 5, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND TAPE WAS USED. WHILE DOING THE PROCEDURE NEEDLE GOT DETACHED FROM THE TAPE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958065 ↗
• MalfunctionDec 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CERVICAL CERCLAGE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23922376 ↗

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