According to the FDA notice, Intuitive sent a letter to affected customers recommending the removal of certain staplers. On March 11, 2026, Intuitive recommended that customers remove its 8 mm SureForm 30 Gray Reload curved-tip surgical stapler from where it is used or sold. The company instructed to immediately identify and stop use of the affected product. At this time, the company recommends using alternative options. Customers can continue to use the curved-tip stapler with blue and white reloads. Only the 8mm SureForm 30 Gray Reloads are subject to recall.
The staplers work with a compatible da Vinci surgical robot for resection, transection of vasculature and tissue and/or creation of anastomoses in general, thoracic, gynecologic, urologic and pediatric surgery.
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Intuitive identified instances of incomplete staple lines with the affected product. This occurred after the da Vinci surgical robot returns a completed stapler fire with Gray reloads on blood vessels. Incomplete staple line formation on blood vessels results in surgically cut tissue. This fully exposes the contents of the cut vessel and causes bleeding that may require conversion to an open surgical technique.
As of February 23, 2026, Intuitive reports four serious injuries and one death associated with the issue.
The warning on the surgical staplers marks another hiccup for Intuitive. Last week, the company shared that an unauthorized third party accessed certain internal IT business applications in a cybersecurity incident.
The analysts’ perspective
William Blair analysts Brandon Vazquez, Russell Yuen and Max Kruszeski say they spoke briefly with Intuitive management on the recall. Management stressed that the letter pertains to stapler reloads and not the staplers themselves. This lessens the commercial impact of the recall, the analysts said.
Additionally, they note that Intuitive has alternatives available for affected customers. This should allow surgeons to serve patients with minimal disruption, they said.
While the analysts say they do not know the exact number of reloads impacted, Intuitive noted that use of gray reloads prior to the recall was “relatively low.”
“Altogether, while unfortunate, our initial assessment is that this should not materially impact Intuitive’s business,” the analysts concluded.
Statement from Intuitive
An Intuitive spokesperson shared the following statement with MassDevice via email:
Intuitive’s top priority is patient safety. We are committed to delivering high quality products and services that enable clinicians to provide their patients with safe and effective options for minimally invasive care.
We have asked all customers who ordered 8 mm SureForm 30 gray stapler reloads on or before Feb. 20, 2026 to identify, quarantine, and return all unused reloads of this product to Intuitive. Suitable alternatives are available, which should enable surgeons to continue to serve patients with minimal disruption.
Intuitive is aware of rare reports of incomplete staple lines using the 8 mm SureForm gray stapler reloads that were correlated to surgical bleeding events. In late December 2025, Intuitive learned of a patient death during a surgery in which the 8 mm SureForm gray stapler reload was used. We are aware of four additional reports of incomplete staple lines using this product that are correlated to surgical bleeding events, between January 2024 and January 2026. None of these reported bleeding incidents occurred post-operatively. The root cause is still under investigation.
The 8 mm Sureform 30 gray reload is one type of staple reload that can be used with the 8mm Sureform 30 Curved-tip stapler, which was FDA cleared in 2021 for use in general, thoracic, gynecologic, urologic, and pediatric surgery.
