MonosofRecalls & reported problems across all models
Covidien LP · 89 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Monosof model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 348
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls
- 2
We found 89 models of Monosof by Covidien LP in the FDA's device registry (GUDID). Together they are named in 348 adverse event reports in the FDA's MAUDE database, received between Mar 31, 2017 and Sep 29, 2026 — classified as 34 injuries, 314 malfunctions.
The most frequently reported specific device problem is “Break” (231 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
Monosof 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.
- Dec 21, 2023Open, Classified
Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.
Z-0845-2024 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
- Dec 2, 2022Open, Classified
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Z-1174-2023 · Root cause: Packaging process control · names 27 of these models · Recall details · FDA record ↗
Most reported Monosof problems
Device problems
- Break231
- Detachment of Device or Device Component112
- Product Quality Problem34
- Patient-Device Incompatibility10
- Unraveled Material5
- Adverse Event Without Identified Device or Use Problem4
- No Apparent Adverse Event3
- Bent2
Patient problems
- No Clinical Signs, Symptoms or Conditions176
- Insufficient Information54
- No Consequences Or Impact To Patient48
- No Known Impact Or Consequence To Patient40
- No Information11
- Local Reaction8
- Swelling8
- No Code Available6
Monosof models
89 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Monosof SN-3695SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 recalls3 reports
- Monosof SN-3697SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall32 reports
- Monosof SN-5697SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall10 reports
- Monosof CN-830-LSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall9 reports
- Monosof GNJ-283SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall5 reports
- Monosof SN-872SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall4 reports
- Monosof CN-724SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall2 reports
- Monosof SN-667GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall2 reports
- Monosof SN-247SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall1 report
- Monosof SN-5691SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall1 report
- Monosof SN-5694SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall1 report
- Monosof SN-5696SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall1 report
- Monosof SN-630SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall1 report
- Monosof SN-643SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall1 report
- Monosof CN-791SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall0 reports
- Monosof CN-793SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall0 reports
- Monosof N-63SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall0 reports
- Monosof SN-1647SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall0 reports
- Monosof SN-1647GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall0 reports
- Monosof SN-3686SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall0 reports
- Monosof SN-3965SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall0 reports
- Monosof SN-5660GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall0 reports
- Monosof SN-5665GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall0 reports
- Monosof SN-5690GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall0 reports
- Monosof SN-5767GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall0 reports
- Monosof SN-694SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall0 reports
- Monosof SN-871SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall0 reports
- Monosof N-2781KSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall0 reports
- Monosof N-2770-KSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE46 reports
- Monosof N-2730-KSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE28 reports
- Monosof GN-283SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE14 reports
- Monosof SN-5699SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE14 reports
- Monosof N-2756KSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE10 reports
- Monosof SN-662SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE10 reports
- Monosof SN-5666SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE9 reports
- Monosof N-2532SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE8 reports
- Monosof SN-669SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE7 reports
- Monosof N-2540SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE6 reports
- Monosof SN-5667SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE6 reports
- Monosof SN-5669SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE6 reports
- Monosof SN-663GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE6 reports
- Monosof SN-664SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE6 reports
- Monosof SN-671SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE6 reports
- Monosof N-2718KSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE5 reports
- Monosof SN-5663SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE5 reports
- Monosof SN-5667GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE5 reports
- Monosof SN-5699GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE5 reports
- Monosof SN-641SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE5 reports
- Monosof SN-5669GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE4 reports
- Monosof SN-764SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE4 reports
- Monosof N-2512SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE3 reports
- Monosof N-2543SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE3 reports
- Monosof N-2546SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE3 reports
- Monosof N-2547SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE3 reports
- Monosof SN-5698GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE3 reports
- Monosof SN-653SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE3 reports
- Monosof SN-660SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE3 reports
- Monosof N-2510SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 reports
- Monosof SN-644SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 reports
- Monosof SN-658SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 reports
- Monosof SN-662GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 reports
- Monosof SN-663SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 reports
- Monosof SN-750SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 reports
- Monosof SN-762SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 reports
- Monosof SN-665SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Monosof CN-225SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Monosof CN-926SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Monosof N-2548SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Monosof N-2716KSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Monosof N-2717-KSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Monosof N-2757KSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Monosof N-2760KSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Monosof N-2799-KSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Monosof SN-1689SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Monosof SN-1964SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Monosof SN-368SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Monosof SN-5666GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Monosof SN-5690SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Monosof SN-5696GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Monosof SN-5698SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Monosof SN-648SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Monosof SN-661GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Monosof SN-664GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Monosof SN-666SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Monosof SN-667SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Monosof SN-688SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Monosof SN-761SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Monosof SN-763SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
- Monosof SN-764GSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 report
Recent Monosof adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
It was reported that during mammary anastomosis, while suturing, the suture broke in the middle.
Patient problems: Insufficient Information
MAUDE report 50935155 ↗MalfunctionSep 22, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860227 ↗MalfunctionSep 22, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860225 ↗MalfunctionSep 22, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860224 ↗MalfunctionSep 15, 2026Break; Detachment of Device or Device Component
It was reported that during a surgical procedure, the sutures were easily ruptured during use, and there were instances where the needle lost attachment from the suture.
Patient problems: Insufficient Information
MAUDE report 50766519 ↗MalfunctionSep 15, 2026Break; Detachment of Device or Device Component
It was reported that during a procedure, the sutures were easily ruptured during use. Multiple defective devices were used in the pr ocedure. There were instances where the needle lost attachment from the suture. As a result of the device issue, the surgical procedure was extended by approximately 15 minutes. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766501 ↗MalfunctionSep 14, 2026Break
Patient problems: Insufficient Information
MAUDE report 50764177 ↗MalfunctionJul 20, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25874882 ↗InjuryJul 9, 2026Product Quality Problem; Unraveled Material
ACCORDING TO THE REPORTER, ONE DAY AFTER A LAPAROSCOPIC VITRECTOMY, THE FIVE SUTURES RUPTURED. THE PATIENT WAS SUBSEQUENTLY READMITTED TO THE HOSPITAL FOR AMBULATORY CARE AND HAD AN ADDITIONAL SURGERY WITH A USE OF A NEW SUTURE FROM A DIFFERENT BRAND. THE PHYSICIAN REPORTED THAT THE COLOR OF THE SUTURES WAS DIFFERED FROM THE LABELING ON THE BOX. THE PACKAGING INDICATED THAT THE SUTURES WERE BLACK; HOWEVER, BEFORE USE, SOME SUTURES WERE GOLD COLORED.
Patient problems: Tissue Breakdown
MAUDE report 25759595 ↗InjuryJul 9, 2026Product Quality Problem; Unraveled Material
ACCORDING TO THE REPORTER, ONE DAY AFTER A LAPAROSCOPIC VITRECTOMY, THE FIVE SUTURES RUPTURED. THE PATIENT WAS SUBSEQUENTLY READMITTED TO THE HOSPITAL FOR AMBULATORY CARE AND HAD AN ADDITIONAL SURGERY WITH A USE OF A NEW SUTURE FROM A DIFFERENT BRAND. THE PHYSICIAN REPORTED THAT THE COLOR OF THE SUTURES WAS DIFFERED FROM THE LABELING ON THE BOX. THE PACKAGING INDICATED THAT THE SUTURES WERE BLACK; HOWEVER, BEFORE USE, SOME SUTURES WERE GOLD COLORED.
Patient problems: Tissue Breakdown
MAUDE report 25759594 ↗InjuryJul 9, 2026Product Quality Problem; Unraveled Material
ACCORDING TO THE REPORTER, ONE DAY AFTER A LAPAROSCOPIC VITRECTOMY, THE FIVE SUTURES RUPTURED. THE PATIENT WAS SUBSEQUENTLY READMITTED TO THE HOSPITAL FOR AMBULATORY CARE AND HAD AN ADDITIONAL SURGERY WITH A USE OF A NEW SUTURE FROM A DIFFERENT BRAND. THE PHYSICIAN REPORTED THAT THE COLOR OF THE SUTURES WAS DIFFERED FROM THE LABELING ON THE BOX. THE PACKAGING INDICATED THAT THE SUTURES WERE BLACK; HOWEVER, BEFORE USE, SOME SUTURES WERE GOLD COLORED.
Patient problems: Tissue Breakdown
MAUDE report 25759590 ↗InjuryJul 9, 2026Product Quality Problem; Unraveled Material
ACCORDING TO THE REPORTER, ONE DAY AFTER A LAPAROSCOPIC VITRECTOMY, THE FIVE SUTURES RUPTURED. THE PATIENT WAS SUBSEQUENTLY READMITTED TO THE HOSPITAL FOR AMBULATORY CARE AND HAD AN ADDITIONAL SURGERY WITH A USE OF A NEW SUTURE FROM A DIFFERENT BRAND. THE PHYSICIAN REPORTED THAT THE COLOR OF THE SUTURES WAS DIFFERED FROM THE LABELING ON THE BOX. THE PACKAGING INDICATED THAT THE SUTURES WERE BLACK; HOWEVER, BEFORE USE, SOME SUTURES WERE GOLD COLORED.
Patient problems: Tissue Breakdown
MAUDE report 25759556 ↗MalfunctionMay 6, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, THE SUTURES BROKE IN THE MIDDLE WHILE SUTURING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THE EVENT WAS ASSOCIATED WITH A PATIENT, AND THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY AND NO CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25090393 ↗MalfunctionMay 6, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, TWO SUTURES BROKE IN THE MIDDLE WHILE SUTURING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THE EVENT WAS ASSOCIATED WITH A PATIENT, AND THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY AND NO CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25090392 ↗MalfunctionMay 1, 2026Break
IT WAS REPORTED THAT DURING UMBILICAL CATHETERIZATION, THE THREAD BROKE WHEN TIGHTENING THE KNOT DURING THE PROCEDURE. NO EXTRA FORCE WAS USED WHEN TYING. IT WAS FURTHER REPORTED THAT THIS ISSUE OCCURRED ON A TOTAL OF THREE DEVICES. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25061913 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 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.
How reports and recalls are matched · Editorial policy · Report an error on this page