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

Class I
Recalling firm
Intuitive Surgical, Inc.
Reason for recall
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
Affected products (lot / model / serial)
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
Firm location
Sunnyvale, CA, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
E-Mail
Product type
Devices
Status
Ongoing
Recall number
Z-1855-2026
Recall initiated
March 11, 2026
FDA classification date
May 1, 2026
FDA report date
May 13, 2026
FDA event ID
98525
Last updated on HTM Vibe
July 24, 2026
View on openFDA