Z-1855-2026Class I

Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06

Name: Z-1855-2026 Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Creator: Intuitive Surgical, Inc.
Published: 2026-03-11
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2026-03-11 / Open, Classified

FDA source

Intuitive Surgical, Inc. began a recall of Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06 on 2026-03-11. FDA classified it as Class I and gives the reason as "Reloads for curved-tipped stapler may potentially produce an incomplete staple line". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1855-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-03-11
Posted: 2026-05-01
Recalling firm: Intuitive Surgical, Inc.
Product: Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
FDA root cause: Under Investigation by firm
Action: 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.
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 codes and lots: UDI:00886874121931/All serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1855-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1855-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-01

Product code NAY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)