FDA Early Alert: Surgical Stapler Issue Linked to Bleeding, Death

CDRH is issuing this Early Alert **to notify the public of a potentially high-risk device issue.* The FDA will keep the public informed and update this web page as significant new information becomes available.*

Affected Product

The FDA is aware that Intuitive Surgical has issued a letter to affected customers recommending certain curved-tip staplers be removed from where they are used or sold.

Affected devices:

• Product Name: 8mm SureForm 30 Gray Reload
• Part Numbers: 48230M-05, 48230M-06
• Unique Device Identifier: 00886874121931

What to Do

Immediately identify and stop use of affected product.

On March 11, 2026, Intuitive Surgical sent all affected customers a letter asking them to take the following actions:

• Identify, stop use, and quarantine all affected product.
• If you have shared or further distributed these products, notify appropriate staff and ensure they locate and return any affected product.
• At this time, Intuitive surgical recommends using alternative options. Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Reason for Alert

Intuitive Surgical has reported instances of incomplete staple lines after the da Vinci Surgical System returns a completed stapler fire with Gray reloads on blood vessels. Incomplete staple line formation on blood vessels will result in tissue being surgically cut and the contents of the cut vessel becoming fully exposed, causing bleeding that may require conversion to an open surgical technique.

As of February 23, 2026, Intuitive Surgical has reported four serious injuries and one death associated with this issue.

Device Use

The Intuitive Surgical 8 mm SureForm 30 Curved-Tip Stapler and 8 mm SureForm 30 Gray Reloads are intended to be used with a compatible da Vinci Surgical System for resection, transection of vasculature and tissue, and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric Surgery.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Intuitive Surgical at customerservice@intusurg.com or (800) 876-1310.

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

• How do I recognize a UDI on a label?
• AccessGUDID database - Identify Your Medical Device
• Benefits of a UDI System

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

• ## Content current as of:

03/18/2026

• Regulated Product(s)

  • Medical Devices