FDA DeviceClass INotable

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

Date: 2026-05-13
Brand: Intuitive Surgical, Inc.
Category: Medical Device
FDA Class: Class I

Description

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

Hazard

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

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