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 SP Recalled by Intuitive Surgical, Inc. Due to Access Port System tray may develop cracks potentially...

Date: December 15, 2025
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 SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)

Quantity: 41,526 units

Why Was This Recalled?

Access Port System tray may develop cracks potentially resulting in a sterility breach.

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