ETHIBOND EXCELRecalls & reported problems across all models
Ethicon, LLC · 134 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one ETHIBOND EXCEL model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 921
- Deaths reported
- 0
- Injuries reported
- 36
- Recalls
- 2
We found 134 models of ETHIBOND EXCEL by Ethicon, LLC in the FDA's device registry (GUDID). Together they are named in 921 adverse event reports in the FDA's MAUDE database, received between Dec 5, 2017 and Sep 29, 2026 — classified as 36 injuries, 885 malfunctions.
The most frequently reported specific device problem is “Material Separation” (516 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
ETHIBOND EXCEL 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-1516-2025 · Root cause: Process control · 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-1097-2025 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
Most reported ETHIBOND EXCEL problems
Device problems
- Material Separation516
- Break279
- Device Contaminated During Manufacture or Shipping29
- Material Frayed24
- Adverse Event Without Identified Device or Use Problem18
- Component Misassembled18
- Delivered as Unsterile Product16
- Tear, Rip or Hole in Device Packaging11
Patient problems
- No Clinical Signs, Symptoms or Conditions718
- No Consequences Or Impact To Patient167
- Foreign Body In Patient11
- Unspecified Infection10
- Wound Dehiscence8
- Inflammation7
- Abscess4
- Insufficient Information4
ETHIBOND EXCEL models
134 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- ETHIBOND EXCEL X557HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE187 reports
- ETHIBOND EXCEL X872HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall15 reports
- ETHIBOND EXCEL X425HSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE1 recall12 reports
- ETHIBOND EXCEL X843HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall6 reports
- ETHIBOND EXCEL MB66GSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE42 reports
- ETHIBOND EXCEL X834HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE30 reports
- ETHIBOND EXCEL X523HSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE26 reports
- ETHIBOND EXCEL PXX77NSuture, nonabsorbable, synthetic, polyethylene25 reports
- ETHIBOND EXCEL X519HSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE23 reports
- ETHIBOND EXCEL D10068SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE22 reports
- ETHIBOND EXCEL CX21DSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE21 reports
- ETHIBOND EXCEL X951HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE21 reports
- ETHIBOND EXCEL X551HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE17 reports
- ETHIBOND EXCEL MX69GSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE16 reports
- ETHIBOND EXCEL X4843GSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE16 reports
- ETHIBOND EXCEL X524HSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE14 reports
- ETHIBOND EXCEL MB46GSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE13 reports
- ETHIBOND EXCEL X905HSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE13 reports
- ETHIBOND EXCEL PXX52SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE12 reports
- ETHIBOND EXCEL D7931SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE11 reports
- ETHIBOND EXCEL X558HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE11 reports
- ETHIBOND EXCEL X762HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE11 reports
- ETHIBOND EXCEL X763HSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE11 reports
- ETHIBOND EXCEL X833HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE11 reports
- ETHIBOND EXCEL D10069SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE11 reports
- ETHIBOND EXCEL CX30DSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE10 reports
- ETHIBOND EXCEL CX41DSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE10 reports
- ETHIBOND EXCEL MX552SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE10 reports
- ETHIBOND EXCEL MX553SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE10 reports
- ETHIBOND EXCEL X31044HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE10 reports
- ETHIBOND EXCEL CX46DSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE9 reports
- ETHIBOND EXCEL X424HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE8 reports
- ETHIBOND EXCEL X522HSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE8 reports
- ETHIBOND EXCEL X588HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE8 reports
- ETHIBOND EXCEL W4846Suture, nonabsorbable, synthetic, polyamide8 reports
- ETHIBOND EXCEL X411HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE7 reports
- ETHIBOND EXCEL PXX43SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE6 reports
- ETHIBOND EXCEL PXX82SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE6 reports
- ETHIBOND EXCEL PXX87SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE6 reports
- ETHIBOND EXCEL SX54HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE6 reports
- ETHIBOND EXCEL SXX50SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE6 reports
- ETHIBOND EXCEL X444HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE6 reports
- ETHIBOND EXCEL X832HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE6 reports
- ETHIBOND EXCEL X926HSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE6 reports
- ETHIBOND EXCEL MB47GSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE5 reports
- ETHIBOND EXCEL PXX50SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE5 reports
- ETHIBOND EXCEL PXX86SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE5 reports
- ETHIBOND EXCEL SX17HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE5 reports
- ETHIBOND EXCEL 10X82SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE4 reports
- ETHIBOND EXCEL D6165SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE4 reports
- ETHIBOND EXCEL D7435SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE4 reports
- ETHIBOND EXCEL MX944SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE4 reports
- ETHIBOND EXCEL PX82HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE4 reports
- ETHIBOND EXCEL W975GSuture, nonabsorbable, synthetic, polyethylene4 reports
- ETHIBOND EXCEL PXX52NSuture, nonabsorbable, synthetic, polyethylene4 reports
- ETHIBOND EXCEL SXX50NSuture, nonabsorbable, synthetic, polyethylene4 reports
- ETHIBOND EXCEL 10X42SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE3 reports
- ETHIBOND EXCEL 10X53SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE3 reports
- ETHIBOND EXCEL D9306SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE3 reports
- ETHIBOND EXCEL D9541SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE3 reports
- ETHIBOND EXCEL D9999SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE3 reports
- ETHIBOND EXCEL PX65HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE3 reports
- ETHIBOND EXCEL PX83HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE3 reports
- ETHIBOND EXCEL PXX41SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE3 reports
- ETHIBOND EXCEL SXP52SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE3 reports
- ETHIBOND EXCEL X873HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE3 reports
- ETHIBOND EXCEL X936HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE3 reports
- ETHIBOND EXCEL 6965HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE3 reports
- ETHIBOND EXCEL 10X52SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- ETHIBOND EXCEL B499TSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- ETHIBOND EXCEL CX27DSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- ETHIBOND EXCEL CX45DSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- ETHIBOND EXCEL D8226SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- ETHIBOND EXCEL PX62HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- ETHIBOND EXCEL PXX77SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- ETHIBOND EXCEL SXP54SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- ETHIBOND EXCEL SXX54SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE2 reports
- ETHIBOND EXCEL X184HSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE2 reports
- ETHIBOND EXCEL X204HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- ETHIBOND EXCEL X412HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- ETHIBOND EXCEL X556HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- ETHIBOND EXCEL X559HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- ETHIBOND EXCEL X562HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- ETHIBOND EXCEL X581HSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE2 reports
- ETHIBOND EXCEL X695GSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- ETHIBOND EXCEL X727HSUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE2 reports
- ETHIBOND EXCEL X964HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- ETHIBOND EXCEL EC11SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- ETHIBOND EXCEL X4407HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- ETHIBOND EXCEL X893GSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- ETHIBOND EXCEL X32047HSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- ETHIBOND EXCEL D10071NSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE2 reports
- ETHIBOND EXCEL D6090SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE1 report
- ETHIBOND EXCEL D6296SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE1 report
- ETHIBOND EXCEL D7630SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE1 report
- ETHIBOND EXCEL D7810SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE1 report
- ETHIBOND EXCEL D8230SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE1 report
- ETHIBOND EXCEL D8438SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE1 report
- ETHIBOND EXCEL D8449SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
- ETHIBOND EXCEL D9185SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 report
Recent ETHIBOND EXCEL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50937647 ↗MalfunctionSep 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848388 ↗MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828638 ↗MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793834 ↗InjuryAug 28, 2026Positioning Failure
It was reported by a spine surgeon that a patient underwent an unknown procedure on an unknown date and suture was used. Post-op, the patient came back with a wound dehiscence within two weeks post-op. The patient underwent surgical intervention to close the incision that dehisced. The surgeon stated they used this suture to perform an interrupted closure of fascia with a square knot technique, and claims that the knots are too slippery and don't seem to hold as well as a different manufactures suture that he was using previously. The surgeon believes this is why the knots fell apart post-op and caused a dehiscence. Additional information was requested.
Patient problems: Wound Dehiscence
MAUDE report 50497948 ↗InjuryAug 28, 2026Positioning Failure
It was reported by a spine surgeon that a patient underwent an unknown procedure on an unknown date and suture was used. Post-op, the patient came back with a wound dehiscence within two weeks post-op. The patient underwent surgical intervention to close the incision that dehisced. The surgeon stated they used this suture to perform an interrupted closure of fascia with a square knot technique, and claims that the knots are too slippery and don't seem to hold as well as a different manufactures suture that he was using previously. The surgeon believes this is why the knots fell apart post-op and caused a dehiscence. Additional information was requested.
Patient problems: Wound Dehiscence
MAUDE report 50497931 ↗InjuryAug 28, 2026Positioning Failure
It was reported by a spine surgeon that a patient underwent an unknown procedure on an unknown date and suture was used. Post-op, the patient came back with a wound dehiscence within two weeks post-op. The patient underwent surgical intervention to close the incision that dehisced. The surgeon stated they used this suture to perform an interrupted closure of fascia with a square knot technique, and claims that the knots are too slippery and don't seem to hold as well as a different manufactures suture that he was using previously. The surgeon believes this is why the knots fell apart post-op and caused a dehiscence. Additional information was requested.
Patient problems: Wound Dehiscence
MAUDE report 50497893 ↗InjuryAug 28, 2026Positioning Failure
It was reported by a spine surgeon that a patient underwent an unknown procedure on an unknown date and suture was used. Post-op, the patient came back with a wound dehiscence within two weeks post-op. The patient underwent surgical intervention to close the incision that dehisced. The surgeon stated they used this suture to perform an interrupted closure of fascia with a square knot technique, and claims that the knots are too slippery and don't seem to hold as well as a different manufactures suture that he was using previously. The surgeon believes this is why the knots fell apart post-op and caused a dehiscence. Additional information was requested.
Patient problems: Wound Dehiscence
MAUDE report 50497881 ↗MalfunctionAug 25, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50442525 ↗MalfunctionAug 19, 2026Break
It was reported that a patient underwent an unknown procedure on (b)(6)2026 and suture was used. During the procedure, two suture needles each broke into two pieces during use. All pieces of the needles were retrieved and measured against the other two needles from the pack but both scrub nurse and circulating nurse. Incision was washed out by surgical team, surgical team agreed no pieces left in incision. Pieces of all four needles and suture packet handed off sterile field and delivered to management. No adverse patient consequences were reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50329056 ↗MalfunctionAug 19, 2026Break
It was reported that a patient underwent an unknown procedure on (b)(6)2026 and suture was used. During the procedure, two suture needles each broke into two pieces during use. All pieces of the needles were retrieved and measured against the other two needles from the pack but both scrub nurse and circulating nurse. Incision was washed out by surgical team, surgical team agreed no pieces left in incision. Pieces of all four needles and suture packet handed off sterile field and delivered to management. No adverse patient consequences were reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50329030 ↗MalfunctionAug 18, 2026Material Separation
It was reported that a patient underwent a robot-assisted sacrocolpopexy procedure on (b)(6) 2026 and suture was used. During surgery, two of the four needles were detached from the sutures easily and fell into the abdominal cavity during needle retrieval. The situation was resolved after the respective needles were located and retrieved within approximately five minutes. The product was used on the mesh fixation site. It was not a control release needle. No adverse patient consequences were reported. Additional information was requested
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50298809 ↗MalfunctionAug 18, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50298790 ↗MalfunctionAug 17, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50287018 ↗MalfunctionAug 17, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50278235 ↗
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
- 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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