Intuitive Surgical, Inc. — Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
⚠️ Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
Is this relevant to me?
- Geography
- US
- Source agency
- FDA
- Category
- Health
- Published
- March 11, 2026
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
What's affected?
- Product
- Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
- Lot code
- UDI:00886874121931/All serial Numbers
Additional details
UDI:00886874121931/All serial Numbers
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated
Get Health recall alerts
Delivered to your inbox. Free. No account required.