Johnson & Johnson Earns CE Mark for Ethicon 4000 Surgical Stapler

Johnson & Johnson has earned CE mark approval for its Ethicon 4000 stapler, an advanced surgical stapler engineered for reliable staple line integrity for a variety of tissue thicknesses.

The Ethicon 4000 and Ethicon 3D reloads feature proprietary 3D Stapling technology, a redesigned end-effector, and streamlined reload options. Certified for open and laparoscopic surgery in the EU, the tech ad reloads are also planned for future use in the Ottava robotic surgical system.

Thick, fragile, and inconsistent tissue are complex variables that can compromise staple line integrity and consequently, outcomes, J&J cited. Surgeons then routinely intervene to mitigate complications—one study found bariatric surgeons reinforced the staple line through oversew, buttress, or a combination of both in 77% of laparoscopic sleeve gastrectomy cases.

Leaks and bleeding events may also be costly. A UK study showed prolonged air leaks were found to occur in 27% of patients undergoing thoracic surgery, at an average additional 90-days postoperative cost of €5,200 per patient.

J&J said that use of its surgical stapling devices has been related to improved clinical and economic outcomes across tissue types, patient populations, and countries in bariatric, thoracic, and colorectal procedures.

“Surgical complications, including leaks and bleeding events, can impact surgical outcomes, causing distress to both patients and surgeons, and are associated with significant cost implications,” said François Gaudemet, president, Surgery EMEA, MedTech, Johnson & Johnson. “We are building on a long legacy of supporting surgeons and driving innovation for consistent and reliable experiences across open, minimally invasive and robotic surgery.”

The Ethicon 4000 stapler launched in the U.S. in June 2025.