SureForm recallZ-1855-2026 · Intuitive Surgical, Inc. · initiated Mar 11, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Intuitive Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
FDA root cause category: Under Investigation by firm
What the company is doing
On 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.
Recall details
- Recall number
- Z-1855-2026
- Status
- Open, Classified
- Initiated by the company
- Mar 11, 2026
- Posted by the FDA
- May 1, 2026
- Recalling firm
- Intuitive Surgical, Inc.
- Product code
- NAY
- FDA submissions
- K211997, K222839, K241638
- 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
Product description
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Code information (models, lots, serial numbers)
UDI:00886874121931/All serial Numbers
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Sureform 48230MIntuitive Surgical, Inc. · Staple, implantable2 recalls11 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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