Recall
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Intuitive Surgical, Inc. · 11 March 2026
- Status
- Recall open, classified
- Why, in the FDA's words
- “Reloads for curved-tipped stapler may potentially produce an incomplete staple line.”
- Recall began
- 11 March 2026
- Company
- Intuitive Surgical, Inc.
- Device type
- Robot-assisted surgical systems (computer-controlled instruments) (NAY)
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.