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U.S. Department of Health and Human Services

Class 1 Device Recall Intuitive Surgical 8 mm SureForm 30 Gray Reloads

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 Class 1 Device Recall Intuitive Surgical 8 mm SureForm 30 Gray Reloadssee related information
Date Initiated by FirmMarch 11, 2026
Date PostedMay 01, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1855-2026
Recall Event ID 98525
510(K)NumberK211997 K222839 K241638 
Product Classification System, surgical, computer controlled instrument - Product Code NAY
ProductIntuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Code Information UDI:00886874121931/All serial Numbers
FEI Number 3001675293
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd
Sunnyvale CA 94086-5304
For Additional Information ContactCustomer Service
1800-876-1310 Ext. 3
Manufacturer Reason
for Recall		Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 3/17/2026 Intuitive Surgical issued a "urgent Medical Device Recall Notification to affected consignees via E.Mail and FedEx. Intuitive ask consignees to take the following actions: 1. Please identify, discontinue use, and quarantine any affected product(s). Affected product(s) may be returned by calling customer service with quantities and lot numbers to your regional customer service. 2. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 3. Please ensure to include the Recall or FSCA number ISIFA2026-02-R in your return notes. 4. If you have shared or further distributed these products with other sites, please make sure appropriate staff at the site receive and understand this notification so they locate and return their affected product.
DistributionUS: 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NAY
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