FDAFDA · Food and drugs·Recall number Z-1855-2026
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Published May 13, 2026 · Recall initiated: March 11, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Intuitive Surgical, Inc.
- Distributor
- 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
- Lot
- UDI:00886874121931/All serial Numbers
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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