Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Summary
The FDA issued a Class I for Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230 by Intuitive Surgical, Inc.. Reason: Reloads for curved-tipped stapler may potentially produce an incomplete staple line..
Details
Source
Device Recall
External ID
Z-1855-2026
Action Date
2026-05-13
Status
Ongoing
Category
device
Product Description
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Lot/Code Info: UDI:00886874121931/All serial Numbers
Reason for Recall
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-11
Company
Sunnyvale, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 250 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Intuitive Surgical, Inc. has 124 FDA actions in our database, including 73 recalls and 51 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Intuitive Surgical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Intuitive Surgical, Inc. have FDA actions?
Intuitive Surgical, Inc. has 124 FDA actions in our database, including 73 recalls and 51 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1855-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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