Z-1855-2026 Class I Ongoing

Recalled by Intuitive Surgical, Inc. — Sunnyvale, CA

Recall Details

Product Type
Devices
Report Date
May 13, 2026
Initiation Date
March 11, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06

Reason for Recall

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

Distribution Pattern

US: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin OUS: Austria Belgium Denmark Finland France Germany Ireland Italy Japan Netherlands Norway Spain Sweden Switzerland United Kingdom

Code Information

UDI:00886874121931/All serial Numbers