Intuitive Surgical, Inc. recalls Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06

Reloads for curved-tipped stapler may potentially produce an incomplete staple line.

On 3/17/2026 Intuitive Surgical issued a "urgent Medical Device Recall Notification to affected consignees via E.Mail and FedEx. Intuitive ask consignees to take the following actions: 1. Please identify, discontinue use, and quarantine any affected product(s). Affected product(s) may be returned by calling customer service with quantities and lot numbers to your regional customer service. 2. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 3. Please ensure to include the Recall or FSCA number ISIFA2026-02-R in your return notes. 4. If you have shared or further distributed these products with other sites, please make sure appropriate staff at the site receive and understand this notification so they locate and return their affected product.

• FDA enforcement recordOfficial FDA database entry for Z-1855-2026
• FDA 510(k) clearance · K211997The device's official FDA premarket clearance record
• FDA 510(k) clearance · K222839The device's official FDA premarket clearance record
• FDA 510(k) clearance · K241638The device's official FDA premarket clearance record
• FDA device classification · NAYOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.1500The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Intuitive Surgical, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.