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
- 10,734
- Deaths
- 43
- Injuries
- 969
- Malfunctions
- 9,686
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, ImplantableGDW3,605
- Instrument, Ultrasonic SurgicalLFL2,857
- Clip, ImplantableFZP1,866
- Laparoscope, General & Plastic SurgeryGCJ817
- Electrosurgical, Cutting & Coagulation & AccessoriesGEI703
- Applier, Surgical, ClipGDO282
- Instrument, BiopsyKNW170
- Product code KOGKOG94
- Stapler, SurgicalGAG86
- Staple, Removable (Skin)GDT82
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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