Ethicon Endo-surgery, LLC.
FDA adverse event reports naming Ethicon Endo-surgery, LLC. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ETHICON ENDO-SURGERY, LLC..
- Total reports
- 132,640
- Deaths
- 548
- Injuries
- 12,781
- Malfunctions
- 119,063
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Staple, ImplantableGDW59,624
- Instrument, Ultrasonic SurgicalLFL38,559
- Clip, ImplantableFZP18,075
- Laparoscope, General & Plastic SurgeryGCJ6,293
- Electrosurgical, Cutting & Coagulation & AccessoriesGEI5,088
- Applier, Surgical, ClipGDO2,690
- Staple, Removable (Skin)GDT586
- Product code KOGKOG428
- Mesh, Surgical, Absorbable, Staple Line ReinforcementOXC307
- Stapler, SurgicalGAG189
Recent recalls
- 2025-04-03Open, ClassifiedProcess control
PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP
Identified curing issues with the silicone during the needles manufacturing process.
- 2025-04-03Open, ClassifiedProcess control
PDSIIVIO30IN(75CM)USP6-0(M0.7)D/AC-1
Identified curing issues with the silicone during the needles manufacturing process.
- 2025-04-03Open, ClassifiedProcess control
PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
Identified curing issues with the silicone during the needles manufacturing process.
- 2025-04-03Open, ClassifiedProcess control
ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
Identified curing issues with the silicone during the needles manufacturing process.
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