Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

da Vinci Xi/X Tip-Up Fenestrated Grasper Recalled by Intuitive Surgical, Inc. Due to Fenestrated Graspers have a manufacturing issue has the...

Date: June 12, 2023
Company: Intuitive Surgical, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Intuitive Surgical, Inc. directly.

Affected Products

da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12

Quantity: 46,033

Why Was This Recalled?

Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Intuitive Surgical, Inc.

Intuitive Surgical, Inc. has 244 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report