Class I

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

Intuitive Surgical, Inc. · March 11, 2026

Reason for Recall

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

Distribution

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

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1855-2026

Status: ongoing

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