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
- 1,229
- Deaths
- 3
- Injuries
- 102
- Malfunctions
- 1,124
Top device categories
- Staple, ImplantableGDW543
- Instrument, Ultrasonic SurgicalLFL344
- Stapler, SurgicalGAG149
- Clip, ImplantableFZP113
- Electrosurgical, Cutting & Coagulation & AccessoriesGEI24
- Applier, Surgical, ClipGDO18
- Laparoscope, General & Plastic SurgeryGCJ16
- Endoscopic Tissue Approximation DeviceOCW12
- Mesh, Surgical, Absorbable, Staple Line ReinforcementOXC4
- Insufflator, LaparoscopicHIF2
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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