Device product

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

Z-1855-2026

March 11, 2026

Class I

Product summary

Firm: Intuitive Surgical, Inc.
Event: Event 98525
Status: Ongoing
Classification: Class I
Quantity: Unavailable
Official record key: device-enforcement:Z-1855-2026

Official wording

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

Code information: UDI:00886874121931/All serial Numbers

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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