Recall Z-1855-2026

Intuitive Surgical, Inc. · initiated March 11, 2026

Class I Open, Classified

Class I – dangerous or defective products that could cause serious health problems or death

Product

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

Codes / lots: UDI:00886874121931/All serial Numbers

Reason for recall

Reloads for curved-tipped stapler may potentially produce an incomplete staple line.

FDA-determined cause: Under Investigation by firm

Action taken

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.

Details

Recall number
Z-1855-2026
Initiated
March 11, 2026
Posted by FDA
May 1, 2026
Product code
NAY – System, Surgical, Computer Controlled Instrument
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…
Recalling firm
Intuitive Surgical, Inc., Sunnyvale, CA

Official FDA recall record