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
- 2,018
- Deaths
- 5
- Injuries
- 170
- Malfunctions
- 1,843
Top device categories
- Staple, ImplantableGDW816
- Instrument, Ultrasonic SurgicalLFL626
- Stapler, SurgicalGAG228
- Clip, ImplantableFZP208
- Electrosurgical, Cutting & Coagulation & AccessoriesGEI44
- Laparoscope, General & Plastic SurgeryGCJ33
- Applier, Surgical, ClipGDO24
- Endoscopic Tissue Approximation DeviceOCW22
- Mesh, Surgical, Absorbable, Staple Line ReinforcementOXC9
- Apparatus, Pneumoperitoneum, AutomaticFDP2
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.
Monitor Ethicon Endo-surgery, LLC. automatically
DeviceWatch monitors available FDA adverse events and recalls. Growth includes event alerts for Death and Injury reports; Compliance Pro adds safety signals for investigation. FDA publication delays and incomplete collection or analysis coverage limit detection; no signal does not establish the absence of a safety concern. AI summaries and signals are provisional and require human review.