Intuitive Surgical, Inc.: System, Surgical, Computer Controlled Instrument

Recalling firm
Intuitive Surgical, Inc.
Product
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Reason
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-03-11
Status
Open, Classified
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...

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/397cb458-3c98-4130-8e0a-25a904d99d56