Medical device recalls High risk

Intuitive Surgical, Inc. recalls Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06

Recall date
March 11, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1855-2026
FDA classification
Class I
Brand / firm
Intuitive Surgical, Inc.
Sold / distributed
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 Me…

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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

Get recall alerts

Free email alert whenever Intuitive Surgical, Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Intuitive Surgical, Inc.