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Home › FDA recalls › Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers:
CLASS I · SeriousFDA

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

📅 Mar 11, 2026 · 📍 AK, AL, AR, AZ, CA, CO, CT, DC +41
Recalling company
Intuitive Surgical, Inc.
Product
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Reason
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
Classification
Class I – a reasonable probability that use will cause serious adverse health consequences or death
Recall date
Mar 11, 2026
Reported
May 13, 2026
Distribution
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
Status
Ongoing
Lot / codes
UDI:00886874121931/All serial Numbers
Company location
Sunnyvale, CA
Recall type
Voluntary: Firm initiated
Recall number
Z-1855-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1855-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.