⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

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

Medical DevicesSource: FDA (device) · Date: 2026-05-13

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Intuitive Surgical, Inc.
Product
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Reason / hazard
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
Classification
Class I
Status
Ongoing
Distribution / sold at
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
Recall initiated
2026-03-11
Code info
UDI:00886874121931/All serial Numbers
Voluntary mandated
Voluntary: Firm initiated
City
Sunnyvale
State
CA
Country
United States
Event id
98525
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